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Biennial Report of the Director
National Institutes of Health Fiscal Years 2006 & 2007



Appendices

Appendix E:
Monitoring Adherence to the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research


Comprehensive Report: Tracking of Human Subjects Research As Reported in Fiscal Year 2005
and Fiscal Year 2006


Following is an excerpt of the report—all of the report except for the appendices. The full report can be found at:
https://orwh.od.nih.gov/inclusion/2007 Annual Comprehensive Report - Web Version Rev 8-22-07.pdf

NIH Tracking/Inclusion Committee

Vivian W. Pinn, M.D., Co-Chair Office of Research on Women’s Health

Carl Roth, Ph.D., LL.M., Co-Chair National Heart, Lung, and Blood Institute

Angela C. Bates, M.B.A. Office of Research on Women’s Health

Carlos E. Caban, Ph.D. Office of Extramural Research

Kim Jarema Liaison, NIH Clinical Center

Spring 2007

Table of Contents
  Page
Historical Summary and Current Activities
Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
1
Data Analyses and Report of NIH Inclusion Data 9
Summary Data Tables: FY2006 and Twelve-Year Trend Reports
NIH Wide Clinical Research Performed in 2005 and Reported in FY2006
Table 1. Summary of NIH Clinical Research Reported in FY2006: Total Number of Protocols and Enrollment by Sex and Domestic versus Foreign Protocols 19
Table 2. Overview of NIH Extramural and Intramural Clinical Research Reported in FY2006: Number of Sex- Specific Protocols and enrollment, and Domestic versus Foreign Protocols 21
Table 3. Summary of NIH Phase III Clinical Research Reported in FY2006: Total Number of Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols 23
Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported in FY2006: Number of Sex-Specific Protocols and Enrollment, and Domestic versus Foreign Protocols 25
Trend Summary Reports: FY1995-2006
Table 5. Twelve-Year Trend for Protocol and Enrollment Data 27
Table 6. Twelve-Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research reported in FY1995-2006: Enrollment by Race and Ethnicity 30
Table 7. Twelve-Year Minority Trend Summary of NIH Phase III Extramural and Intramural Clinical Research Reported in FY1995-2006: Enrollment by Race and Ethnicity 33
Domestic and Foreign Clinical Research: Trend Reports FY2002-2005
Table 8. DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research Reported in FY2002-2006: Enrollment Using U.S. Race and Ethnicity Categories 36
Table 9. DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in FY2002-2006: Enrollment Using U.S. Race and Ethnicity Categories 38
Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research Reported in FY2002-2006: Enrollment Using U.S. Race and Ethnicity Categories 40
Table 11. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in FY2002-2006: Enrollment Using U.S. Race and Ethnicity Categories 42


APPENDICES
Appendix A Historical Narrative on the Implementation of the NIH Inclusion Policy 47
Appendix B Explanation of Gender and Minority Codes 58
Appendix C NIH Tracking and Inclusion Committee Member List 61
Appendix D Internet Homepage: Inclusion of Women and Minorities Policy Implementation 67
Appendix E NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001 71
Appendix F NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research 87
Appendix G NIH Inclusion Tables for Target and Enrollment Data 99
Appendix H Comparison of 1977 and 1997 OMB Classifications for Reporting Race and Ethnicity 105
Appendix I FY2006 Aggregate Extramural and Intramural Data Tables 109


Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

The establishment and implementation of policies for the inclusion of women and minorities in clinical research funded by the National Institutes of Health (NIH) has its origins in the women’s health movement. Following the issuance of the report of the Public Health Service Task Force on Women’s Health in 1985, the NIH established a policy in 1986 for the inclusion of women in clinical research. This policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and Contracts in 1987. Later that year, minority and other scientists at the NIH recognized the need to address the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a policy encouraging the inclusion of minorities in clinical studies was first published.

In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made what had previously been policy into Public Law, through a section in the NIH Revitalization Act of 1993 (PL 103-43)1, entitled Women and Minorities as Subjects in Clinical Research. In 1994, the NIH revised its inclusion policy to meet this mandate that women and minorities must be included in all of its clinical research studies. The Revitalization Act essentially reinforced the existing NIH policies, but with four major differences:
  • that NIH ensure that women and minorities and their subpopulations be included in all clinical research;
  • that women and minorities and their subpopulations be included in Phase III clinical trials in numbers adequate to allow for valid analyses of differences in intervention effect;
  • that cost is not allowed as an acceptable reason for excluding these groups; and,
  • that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies
Revised inclusion guidelines developed in response to this law were published in the Federal Register2 in March 1994, and they became effective in September 1994. The result was that NIH could not and would not fund any grant, cooperative agreement or contract or support any intramural project to be conducted or funded in Fiscal Year 1995 and thereafter which did not comply with this policy.

Strategies to ensure uniform implementation of the revised guidelines across the NIH were developed through the establishment and deliberations of an NIH Tracking and Inclusion Committee made up of representatives of the directors of each of the ICs. This trans-NIH committee, convened by the Office of Research on Women’s Health (ORWH) and co-chaired with a senior IC official, meets on a regular basis, focusing on consistent and widespread adherence to the NIH guidelines by all the ICs. Working in collaboration with the Office of Extramural Research (OER), the Office of Intramural Research (OIR), and other components of the NIH, the ORWH coordinates the activity of developing and establishing data collection and reporting methodologies to ensure uniform standards and definitions in the reporting of data on women and minority participants in NIH-funded clinical research.

To ensure NIH-wide adherence to the revised inclusion guidelines, in 1994 NIH conducted extensive training on the revised inclusion guidelines. In June 1994, the ORWH convened a meeting of Institutional Review Board (IRB) chairs to discuss their role in implementing the revised policy. Training was especially important in light of 1990 GAO findings that an earlier policy was inconsistently applied and had not been well communicated or understood within the NIH or in the research community. A variety of outreach activities were initiated to explain the revised policy to the scientific research community and to clear up common misunderstandings about the new requirements.

Continuing Implementation and Monitoring Activities

Following a Congressional request for an assessment of NIH’s progress in implementing the1994 guidelines on including women in clinical research, the GAO issued another report in May, 2000, entitled Women’s Health - NIH Has Increased Its Efforts to Include Women in Research.3 It concluded that in the past decade, NIH has made significant progress in implementing a strengthened policy on including women in clinical research.

The GAO report also included two specific recommendations to the Director of NIH to ensure the following:
  • that the requirement be implemented that Phase III clinical trials be designed and carried out to allow for the valid analysis of differences between women and men and communicate this requirement to applicants as well as requiring peer review groups to determine whether each proposed Phase III clinical trial is required to have such a study design, and that summary statements document the decision of the initial reviewers; and
  • that the NIH staff who transmit data to the inclusion tracking data system receive ongoing training on the requirements and purpose of the system.
Immediately following the release of this report, an NIH Subcommittee Reviewing Inclusion Issues was formed, consisting of representatives from several ICs, ORWH, OER, and OIR, to reexamine NIH's system for tracking data on the inclusion of women and minorities in clinical research, recommend any necessary changes to improve its accuracy and performance, and reiterate the NIH policy. Several actions resulted to clarify the requirement for NIH-defined Phase III clinical trials to include women and minority groups, if scientifically appropriate, and for analysis of sex/gender and/or racial/ethnic differences to be planned and conducted by investigators engaged in NIH-funded research. Significant actions in 2001 included:
  • Updating the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research and posting it on the ORWH home page https://orwh.od.nih.gov/inclusion.html and NIH web page, Inclusion of Women and Minorities Policy Implementation at: https://grants.nih.gov/grants/funding/women_min/women_min.htm.
  • Developing a new term and condition of award statement for awards made after October 1, 2000 that have NIH-defined Phase III clinical trials.
  • Incorporating language in the NIH solicitations for grant applications and contract proposals to clarify the submission requirement for NIH-defined Phase III clinical trials, a description of plans for sex/gender and/or race/ethnicity analysis including subgroups, if applicable, and reporting accrual annually and results of analyses, as appropriate.
  • Guidelines and instructions for reviewers and Scientific Review Administrators (SRAs) were developed to emphasize and clarify the need to review research proposals that are classified as NIH-defined Phase III clinical trials for both inclusion requirements and issues related to analyses by sex/gender and/or race/ethnicity. Instructions were developed for the proper documentation to include in summary statements to address adherence to these policies.
Training to ensure compliance with this policy was provided to NIH program and review officials, grants and contracts management staff, and current and prospective research investigators. Several initiatives were implemented for review, grants management and program staff since 2000, including specific topics addressing revisions to the NIH Inclusion policy, a grants policy update and Scientific Review Administrator (SRA) orientation on specific issues related to review meetings and proceedings.

The PHS 398 Grant Application was significantly revised to provide additional instructions about the Women and Minorities Inclusion Policy and the revised form became mandatory as of May 10, 2005. These PHS 398 instructions about the Women and Minorities Inclusion Policy have also been included in the new federal application form SF-424 (R&R) for NIH grants using the federal Grants.gov system (see https://era.nih.gov/ElectronicReceipt/). The application instructions included two significant changes in definitions. First, the NIH required use of a revised definition of clinical research that was reported in the 1997 Report of the NIH Director’s Panel on Clinical research and adopted by NIH. Secondly, the Office of Management and Budget (OMB) Directive 15, "Race and Ethnic Standards for Federal Statistics and Administrative Reporting", revised the definitions for the racial and ethnic categories to be used when reporting population data (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html). In addition, NIH policy reemphasized that that NIH-defined Phase III clinical trials must be designed and conducted in a manner to allow for a valid analysis of whether the variables being studied affect women or members of minority groups differently than other subjects.

Many of the training sessions are available electronically for all NIH staff, and the Office of Extramural Research (OER) has made available existing training materials on the Population tracking system website on the NIH Intranet. A training subcommittee of the full NIH Tracking and Inclusion committee has been established to develop new training documents and methods of training for NIH staff and the extramural research community. Further information regarding training initiatives since the 2000 GAO report is discussed in the background section of the Appendices (See Appendix A)

Communication and Outreach Efforts to the Scientific Community

NIH staff provides outreach to the scientific community to help increase understanding of the revised inclusion policy and OMB requirements. These training and outreach efforts are designed to improve understanding of the sex/gender and minority inclusion policy and assist investigators and NIH staff to appropriately address these issues throughout the research grant and contract process. Investigators are instructed to address women and minority inclusion issues in the development of their applications and proposals for clinical research.

Reference documents such as the Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research (https://orwh.od.nih.gov/inclusion/outreach.pdf) and the Frequently Asked Questions (FAQs) for the Inclusion , Recruitment and Retention of Women and Minority Subjects in Clinical Research (https://orwh.od.nih.gov/inclusion/outreachFAQ.pdf) have been published and distributed for investigators and NIH staff. These publications discuss the elements of recruitment and retention, the NIH inclusion policy, 1997 OMB requirements for reporting race and ethnicity data, as well as information for application submission, peer review, and funding. Both are posted on the ORWH website https://orwh.od.nih.gov as well as on the NIH website for the inclusion of women and minorities policy implementation at: https://grants1.nih.gov/grants/funding/women_min/women_min.htm. The revised Outreach Notebook and FAQs continue to be available to the research community to further explore the inclusion policy and its intent. Additionally, a slide show available electronically and in hard copy, "Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need to Know!" was developed for NIH staff to assist them in working with the extramural community.

Monitoring Compliance: Extramural and Intramural Population Data Analysis

When assessing inclusion data, enrollment figures should not be directly compared to the national census figures. The goal of the NIH policy is not to satisfy any quotas for proportional representation, but rather to conduct biomedical and behavioral research in such a manner that the scientific knowledge acquired will be generalizable to the entire population of the United States. The numbers of women or minority subgroups included in a particular study depends upon the scientific question addressed in the study and the prevalence among women and minority subpopulations of the disease, disorder, or condition under investigation.

Scientific Review Groups are instructed to focus on scientific considerations when assessing the planned enrollment for a particular study. The Scientific Review Group (SRG) determines if the implementation plan for an application is unacceptable if it: 1) fails to provide sufficient information about target enrollment; 2) does not adequately justify limited or lack of inclusion of women or minorities; or 3) does not realistically address recruitment and retention. For NIH-defined Phase III clinical trials, the Scientific Review Group (SRG) also evaluates the description of plans to conduct analyses, as appropriate, to address differences in the intervention effect by sex/gender and/or racial/ethnic groups. Applications with unacceptable inclusion plans cannot be funded until NIH staff is assured that revised inclusion plans from the investigators meet the inclusion policy requirements. Research awards covered by this policy require the grantee to report annually on enrollment of women and men, and on the race and ethnicity of research participants so that accrual can be monitored.

NIH has monitored aggregate demographic data for study populations through the evolving NIH computerized tracking system since fiscal year 1994, and tracking the inclusion of women and minorities in clinical studies is well established in all ICs. Members of the NIH Tracking and Inclusion Committee continuously work on ways to refine and improve data collection methods and the quality of the data entered by each IC into this system. In May 2002, the NIH successfully deployed a new population tracking system for monitoring the inclusion of women and minorities in clinical research. This system provides easier data entry and project monitoring of investigator data reporting for NIH staff. An eRA Population Tracking User Group consisting of representatives from several ICs provides continuous feedback related to system use.

The aggregate data enable the NIH to measure inclusion in order to formulate more specific questions about gaps in enrollment and to design studies to respond to those questions. Data compiled in future years allows for longitudinal examination of trends and continued monitoring of compliance, although this will be more difficult for minority trends because of a change in how these data are collected (see next section).

A review of intramural inclusion data indicates that the intramural research program continues to be compliant with the reporting requirements adhered to by the extramural community and outlined in the NIH Implementation Guidelines on the Inclusion of Women and Minority Subjects in Research Studies. The Clinical Center Medical Executive Committee (MEC) has taken a leading role in assuring that investigators conducting clinical research protocols in the Clinical Center are trained and competent in the conduct of clinical research. The MEC designed and endorsed the Standards for Clinical Research within the NIH Intramural Research Program which set forth guidelines for the infrastructure, training, education, and monitoring required for safe and effective conduct of clinical research.

Format Changes for Reporting Race and Ethnicity Data

Beginning in FY2002, NIH changed how data are reported based on the 1997 Office of Management and Budget (OMB) Directive 15 minimum standards for maintaining, collecting and reporting data on race and ethnicity. Implementation of the 1997 OMB standards involved a number of changes including collecting and reporting information on race and ethnicity separately, whereas the 1977 OMB standards used a combined race and ethnicity format. NIH aggregate population data tables describe data using both the 1997 and 1977 OMB standards for reporting data on race and ethnicity. Since 2002, the number of studies reporting data using the 1997 format (NEW FORM) has steadily increased, while the number of studies using the 1977 format (OLD FORM) has steadily decreased as the studies funded prior to FY2002 are completed.

The 1997 OMB reporting format (NEW FORM) and standards does not allow direct comparison of ethnic and racial data with similar data collected under the 1977 OMB reporting format (OLD FORM) and standards because the categories and methods for collecting the data are fundamentally different. Changes in the standardization of definitions and business rules across the NIH for improving the data entered in the population tracking system are reflected in data reported beginning in FY2002. While implementation of these changes will improve the consistency and comparability for future reporting, comparisons with prior FY 2002 data are difficult.

As demonstrated below, the primary differences are: (1) the Hispanic population is considered an ethnic category and reported separately from racial data; (2) there is a separate racial category for Asian population data and Hawaiian and Pacific Islander population data; and 3) respondents are given the option of selecting more than one race. (See Appendix H)

Race and ethnicity data from the OLD and NEW Forms are combined differently as described below for purposes of reporting on the minority population enrolled in NIH clinical research:
  • the OLD FORM uses the 1977 OMB combined Race and Ethnicity Format, which has mutually exclusive categories, and allows Hispanics to be reported as either "Hispanic, Not White" or "White".
  • the NEW FORM uses the 1997 OMB Race and Ethnicity Categories, with separate reporting for Ethnicity (Hispanic or Latino; Not Hispanic or Latino) and Race (Part A); in this format, an individual is classified both by Ethnic Category and by Race Category. Part B of the NEW FORM therefore provides a distribution of only "Hispanics or Latinos" by the five main Race categories. Since minority categories are defined to include both "Hispanic or Latino ethnicity" and non-white racial categories when providing summary totals of minorities, it is necessary to add White Hispanics" and "Unknown/Other Hispanics" based on their ethnicity to the non-white racial categories.
  • Hispanics are defined by country of origin, and may be identified as belonging to any one, or more than one, race category.

OLD FORM (1977) versus NEW FORM (1997)
Race/Ethnicity Category Minority Total Minority Total
  Old Form New Form
OLD FORM: Combined 1977 OMB Race/Ethnicity Categories
     
American Indian/Alaska Native X  
Asian/Pacific Islander X  
Black or African American X  
Hispanic, Not White X  
White    
Unknown/Other    

NEW FORM: Separate 1997 OMB Race/Ethnicity Categories
Part A: Total Enrollment Report
Ethnic Category
Hispanic or Latino**
Not Hispanic or Latino
Unknown (ethnicity not reported)
Ethnic Category Total of All Subjects*
   
Racial Categories
American Indian/Alaska Native   X
Asian   X
Black or African American   X
Hawaiian/Pacific Islander   X
White    
More Than One Race   X
Unknown/Other    
Racial Categories: Total of all Subjects*    
 
Part B: Hispanic Enrollment by RACE    
American Indian/Alaska Native    
Asian    
Black or African American    
Hawaiian/Pacific Islander    
White (Hispanic)   X
More Than One Race    
Unknown/Other (Hispanic)   X
Racial Categories: Total of Hispanics or Latinos**

* The "Ethnic Category Total of All Subjects" must be equal to the "Racial Categories: Total of All Subjects"
** The "Hispanic or Latino"(Part A) must be equal to "Racial Categories: Total of Hispanics or Latinos"(Part B).

DEFINITIONS:
Clinical Research as defined by the 1997 Report of the NIH Director’s Panel on Clinical Research,

https://www.nih.gov/news/crp/97report/execsum.htm
  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies;
  2. Epidemiologic and behavioral studies; and
  3. Outcomes research and health services research

NIH-Defined Phase III Clinical Study

For the purpose of these guidelines, an NIH-defined “clinical trial” is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Valid Analysis

The term “valid analysis” means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are:
  • allocation of study participants of both sexes/genders (males and females) and different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization,
  • unbiased evaluation of the outcome(s) of study participants, and
  • use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the sex/gender and racial/ethnic groups.

Significant Difference

For purposes of this policy, a “significant difference” is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used “statistically significant difference,” which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.

Domestic Organization

A public (including a State or other governmental agency) or private non-profit or for-profit organization that is located in the United States or its territories, is subject to U.S. laws, and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.

Foreign Institution

An organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed PI.

Conclusion and Current Status

NIH staff continues to monitor, document, and work with grantees and contractors to ensure compliance with the inclusion policy. Program Officials provide technical assistance to investigators as they develop their applications and proposals throughout the application process. Review Officials introduce and discuss with reviewers the Guidelines/Instructions for reviewing the Inclusion of Women and Minorities in Clinical Research as well as the instructions and requirements for designing Phase III Clinical Trials in order that valid analyses can be conducted for sex/gender and ethnic/racial differences. At the time of award and submission of progress reports, program officials monitor and verify that inclusion policy requirements are met. When new and competing continuation applications that are selected for payment are deficient in meeting policy requirements, grants management staff and program officials are required to withhold funding until the principal investigator has satisfactorily addressed the policy requirements.

References

  1. Public Law 103-43. National Institutes of Health Revitalization Act of 1993. 42 USC 289 (a)(1).
  2. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 59 Fed. Reg. 14508-14513 (1994).
  3. Women’s Health: NIH Has Increased Its Efforts to Include Women in Research (GAO/HEHS-00- 96, May, 2000).
  4. NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, NIH Guide for Grants and Contracts, Amended 2001.
For Additional Information on the implementation of the inclusion policy, please visit:

NIH Office of Extramural Research Inclusion of Women and Minorities Policy Implementation Website: https://grants.nih.gov/grants/funding/women_min/women_min.htm

Revitalization Act of 1993, 42 USC 289 (a)(1): https://grants.nih.gov/grants/guide/notice-files/not94-100.html

NIH Policy on Reporting Racial and Ethnicity Data: Subjects in Clinical Research, NIH Guide for Grants and Contracts Web page: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html

Office of Research on Women’s Health Website: https://orwh.od.nih.gov/inclusion.html

Aggregate Enrollment Data Tables For Extramural and Intramural Research Protocols


Fiscal Year 2006 Summary Reports

Twelve-year Trend Summary Reports


Summary Report of NIH Inclusion Data

NIH AGGREGATE POPULATION DATA REPORTED IN FY2005 AND FY2006


The following section is provided in order to guide consideration of the data especially in trend of human subjects participation in NIH-funded extramural and intramural clinical research. Because new studies are added each year and other studies are ending, it is not appropriate to compare data over time or to compare data with census population data. Looking at the trend data represents the best interpretation of the aggregate data. Data on inclusion is tabulated from human subject populations in NIH-defined Phase III clinical trials and other human subject research studies. NIH clinical research studies are determined in accordance with the NIH definition of clinical research to include, for example, non-intervention clinical research, clinical trials, epidemiologic studies, behavioral studies, and database studies.

Analysis of aggregate NIH data on inclusion for FY2005 and FY2006 document that substantial numbers of women and men, especially non-minority men, and minorities have been included as research subjects in NIH-defined Phase III clinical trials and other human subject research studies during these fiscal years. Because the data included in the tables are aggregate data from across NIH, it does provide documentation of the tracking and inclusion across the NIH, and some degree of analysis of the data. But caution should be utilized in not over-interpreting the figures that are provided. The NIH Tracking and Inclusion committee has provided for the reader’s interest, conclusions that can be reasonably drawn from the data.

Previous inclusion reports and aggregate enrollment figures for women, men and minority groups for FY1994 to the present can be found on the ORWH website at https://orwh.od.nih.gov/inclusion.html. For this report, the FY2005 and FY2006 data tables have been reformatted and some tables may vary slightly or differ from prior reported summary data in an effort to better clarify reporting.

NIH CLINICAL RESEARCH: Fiscal Years 2005 and 2006


In FY2005, there were 14,798 extramural and intramural clinical research protocols, including Phase III and other clinical studies, of which 10,233 protocols reported human subject participation. Of these, 96.4% were domestic protocols and 3.6% were foreign protocols. Approximately 15.7 million participants were enrolled in extramural and intramural research protocols of which 80.6% were domestic participants and 19.4% were foreign participants. Of the 15.7 million participants, 60.4% were women, 37.8% were men and 1.8% did not provide sex identification. Further, 39.7% of the total participants, and 27.4% of the Domestic-only participants, were reported as minorities following the OMB categories for race and ethnicity. (Table 6)

Correspondingly, in FY2006 there were 15,320 extramural and intramural clinical research protocols, including Phase III and other clinical studies, of which 10,758 protocols reported human subject participation as noted in this report’s trend summary tables. Of these, 95.7% were domestic protocols and 4.3% were foreign protocols. Approximately 14.8 million participants were enrolled in extramural and intramural research protocols of which 77.0% were domestic participants and 23.0% were foreign participants. Of the 14.8 million participants, 63.9% were women, 34.9% were men and 1.3% did not provide sex identification. Further, 43.1% of the total participants, and 28.9% of the Domestic-only participants, were reported as minorities following the OMB categories for race and ethnicity. (Table 1 )

While the number of participants in all extramural and intramural clinical research decreased (15.7M in FY2005 and 14.8M in FY2006), there was no significant change in the ratio of women and men (60.4%F and 37.8%M in FY2005; and 63.9%F and 34.9%M in FY2006). One large study involving approximately 1.6M participants that ended in FY2005 and therefore was not included in the FY2005 figures, accounted for the net decreased number of participants reported.

NIH Defined Phase III Clinical Research: FY2005 and FY2006
In FY2005, there were 665 extramural and intramural Phase III clinical research protocols, of which 547 protocols reported human subject participation. Of these, 94.5% were domestic protocols and 5.5% were foreign protocols. Approximately 493,000 participants were enrolled in extramural and intramural Phase III research protocols of which 88.8% were domestic participants and 11.2% were foreign participants. Of the 493,000participants, 59% were women, 40% were men and 1% did not provide sex identification. Further, 31.3% of the total participants, and 25.1% of the Domestic-only participants, in Phase III clinical research were reported as minorities following the 1997 OMB categories for race and ethnicity. (Table 7)

According to the trend summaries in this report , of the 210 extramural and intramural Phase III research protocols that report following the 1977 OMB standards, minority representation was highest for Blacks (not Hispanic) at 12.5 % and lowest for American Indian/Alaska Natives at 0.4%. Hispanics represented approximately 6.9%, Asian/Pacific Islanders were 5.6% and Whites (not Hispanic) 73.2% of the participants. The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards. (Table 7)

Furthermore, in FY2005, there were 337 extramural and intramural Phase III research protocols reporting data following the current 1997 OMB standards for reporting by both race and ethnicity. Accordingly, minority representation by race was highest for Blacks at 28.5% and lowest for Hawaiian/Pacific Islanders 0.3%. Asians represented 5.2%, American Indian/Alaska Natives 1.2% and Whites 57.3% of participants. Participants identifying as More Than One Race were 1.7% of the total number of participants. In addition, 5.8% did not identify a race category. Of the 337 extramural and intramural Phase III research protocols designating an ethnicity in FY2005, 88.6 % of total participants identified as "Not Hispanic", 5.9% of the total participants identified as "Hispanic or Latino" and 5.5% of the total participants did not identify an ethnicity category. The racial distribution of the "Hispanic or Latino" participants is also provided separately. (Table 7)

Correspondingly, in FY2006 there were 760 extramural and intramural Phase III clinical research protocols, of which 624 protocols reported human subject participation as noted in this report’s trend summary tables. Of these, 90.4% were domestic protocols and 9.6% were foreign protocols. Approximately 499,430 participants were enrolled in extramural and intramural Phase III research protocols of which 80.2% were domestic participants and 19.8% were foreign participants. Of the 499,430 participants, 62.9% were women, 36.0% were men and 1.1% did not provide sex identification. Further, 33.5% of the total participants, and 20.7% of Domestic-only participants, in Phase III clinical research were reported as minorities following the OMB categories for race and ethnicity. (Table 3)

According to the trend summaries in this report, of the 215 extramural and intramural Phase III research protocols that report following the 1977 OMB standards in FY2006, minority representation was highest for Blacks (not Hispanic) at 8.9% and lowest for American Indian/Alaska Natives at 0.4%. Hispanics represented approximately 4.1%, Asian/Pacific Islanders were 7.3% and Whites (not Hispanic) 76.5% of the participants. The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards. (Table 7)

Moreover, in FY 2006, there were 409 extramural and intramural Phase III research protocols reporting data following the current 1997 OMB standards for reporting by both race and ethnicity. Accordingly, minority representation by race was highest for Blacks at 18.8% and lowest for Hawaiian/Pacific Islanders 0.2%. Asians represented 12.0%, American Indian/Alaska Natives 1.7% and Whites 47.0% of participants. Participants identifying as More Than One Race were 1.6% of the total number of participants. In addition, 18.7% did not identify a race category. Of the 409 extramural and intramural Phase III research protocols designating an ethnicity in FY2006, 75.0 % of total participants identified as "Not Hispanic", 11.5 % of the total participants identified as "Hispanic or Latino", and 13.5% of the total participants did not identify an ethnicity category. The racial distribution of the "Hispanic or Latino" participants is also provided separately. (Table 7)

While the number of participants in Phase III extramural and intramural clinical research slightly increased (493,000 in FY2005 and 499,430 in FY2006), there was no significant change in the ratio of women and men (59.0% F and 40.0%M in FY2005; and 62.9%F and 36.0%M in FY2006).

The following sections provide data on extramural research and intramural research separately.

EXTRAMURAL CLINICAL RESEARCH: Fiscal Years 2005 and 2006


In FY2005, there were 13,003 extramural clinical research protocols, including Phase III and other clinical studies, of which 8,763 protocols reported human subject participation as noted in this report’s trend summary tables. Approximately 13.8 million participants were enrolled in extramural research protocols of which 62.1% were women, 36.1% were men and 1.9% did not provide sex identification. (See 2006 Report, Table 2 and Appendix table 3A)

Correspondingly, in FY2006, there were 13,522 extramural clinical research protocols, including Phase III and other clinical studies, of which 9,235 protocols reported human subject participation. Of these, 95.7% were domestic protocols and 4.3% were foreign protocols. Approximately 13.02 million participants were enrolled in extramural research protocols of which 76.6% of the total enrollment is domestic participants and 23.4% of the total enrollment is foreign participants. Of the 13.02 million participants, 65% were women, 33.8% were men and 1.2% did not provide sex identification. Further, 45.9% of the total participants were reported as minorities following the OMB categories for race and ethnicity. (Table 2 and Appendix Table 3A)

While the number of participants in all extramural clinical research decreased (13.8 million in FY2005 and 13.02 million in FY2006), there was no significant change in the ratio of women and men (62%F and 36%M in FY2005 and 65%F and 34%M). However, when sex-specific studies were excluded, the proportions of women and men in all extramural clinical research were proportional to the percentages of the general population. (52.4%F and 45.8 % M)

NIH Defined Phase III Extramural Clinical Research: FY2005 and FY2006
In FY2005 of the 273 extramural Phase III research protocols that report following the 1977 OMB standards, minority representation was highest for Blacks (not Hispanic) at 12.9% and lowest for American Indian/Alaska Natives at 0.4%. Hispanics represented approximately 7%, Asian/Pacific Islanders were 1.9% and Whites (not Hispanic) 76% of the participants. The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards. (See 2006 Report)

In FY2006 there were 707 extramural Phase III clinical research protocols, of which 580 protocols reported human subject participation as noted in this report‘s trend summary tables. Approximately 467,954 participants were enrolled in extramural Phase III research protocols of which 63.5% were women, 35.4% were men and 1% did not provide sex identification. (Table 4 and Appendix Table 5A)

According to trend summaries in the 2006 report, in FY2005, there were 621 extramural Phase III clinical research protocols, of which 511 protocols reported human subject participation. Of these, 88.5% were domestic protocols and 4.9% were foreign protocols. Approximately 465,956 participants were enrolled in extramural Phase III research protocols of which 86% of total enrollment is domestic participants and 8.6% of total enrollment is foreign participants. Of the 465,956 participants, 59.5% were women, 39.5% were men and 1% did not provide sex identification. Further, 29.9% of the total participants in Phase III clinical research were reported as minorities following the OMB categories for race and ethnicity. (See 2006 Report, Table 4 and Appendix Table 5A)

Correspondingly, in FY2006, there were 382 extramural Phase III research protocols reporting data following the current 1997 OMB standards for reporting race and ethnicity. Accordingly, minority representation by race was highest for Blacks at 19.7% and lowest for Hawaiian/Pacific Islanders 0.2%. Asians represented 12.67%, American Indian/Alaska Natives 1.8% and Whites 46.32% of participants. Participants identifying as More Than One Race were 15% of the total number of participants. In addition, 17.8 % did not identify a race category. Of the 382 extramural Phase III research protocols designating an ethnicity in FY 2006, 75.8 % of total participants identified as "Not Hispanic", 11.14 % of the total participants identified as "Hispanic or Latino", and 13.1 % of the total participants did not identify an ethnicity category. The racial distribution of the "Hispanic or Latino" participants is also provided separately. (Appendix Table 5A)

In FY 2005, there were 319 extramural Phase III research protocols reporting data following the current 1997 OMB standards for reporting race and ethnicity. Accordingly, minority representation by race was highest for Blacks at 30.00 % and lowest for Hawaiian/Pacific Islanders 0.28%. Asians represented 5.44%, American Indian/Alaska Natives 1.30% and Whites 55.75% of participants. Participants identifying as More Than One Race were 1.56% of the total number of participants. In addition, 5.66 % did not identify a race category. Of the 319 extramural Phase III research protocols designating an ethnicity in FY2005, 88.7 % of total participants identified as "Not Hispanic", 5.98 % of the total participants identified as "Hispanic or Latino", and 5.32 % of the total participants did not identify an ethnicity category. The racial distribution of the "Hispanic or Latino" participants is also provided separately. (See 2006 Report, Appendix Table5A)

Of the 192 extramural Phase III research protocols that report following the 1977 OMB standards, minority representation was highest for Blacks (not Hispanic) at 13.03 and lowest for American Indian/Alaska Natives at 0.4%. Hispanics represented approximately 7.23%, Asian/Pacific Islanders were 1.81% and Whites (not Hispanic) 76.1% of the participants. The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards. (See 2006 Report, Appendix Table 5A)

While the number of participants in Phase III extramural clinical research protocols slightly increased, there was also some change in the ratio of women and men (59.5%F and 39.5%M in FY2005 and 63.5 %F and 35.4% M in FY2006).

INTRAMURAL CLINICAL RESEARCH: Fiscal Years 2005 and 2006


Substantial numbers of women and minorities were included in NIH intramural studies in FY 2005 and FY2006.

In FY2005, there were 1,795 intramural clinical research protocols, including Phase III and other clinical studies, of which 1,470 protocols reported human subject participation. Of these, 13.7% of the total protocols were domestic protocols and 0.7% of the total protocols were foreign protocols. Approximately 1.94 million participants were enrolled in intramural research protocols of which 10.4% of the total enrollment is domestic participation and 1.9% of the total enrollment is foreign participation. Of the 1.94 million participants, 48.7% were women, 50.5% were men and 0.79% did not provide sex identification. (See 2006 Report, Table 2 and Appendix Table 7A)

In FY2005, approximately 1.94 million participants were reported in all intramural research including Phase III clinical trials, and other clinical studies. Of the 733 intramural research protocols that report data following the 1977 OMB standards, minority representation was highest for Asian/Pacific Islanders at 17.8% and lowest for American Indian/Alaska Natives at 1.8%. Blacks (not-Hispanic) represented 7.5%, Hispanics 4.7%; and Whites (not Hispanic) 60.9% of the intramural research study population. The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards. (See 2006 Report, Appendix Table 7A)

For the 737 intramural clinical research studies that reported data following the current 1997 OMB standards in FY 2005 the largest racial minority group was Blacks at 4.74% and the smallest racial minority group was Hawaiian/Pacific Islanders at 0.19%. Asians represented 3.1%, American Indian/Alaska Natives 0.42% and Whites 86.2% of participants in all intramural clinical research. Approximately 1% of participants reported More Than One Race as their racial category. In addition, 4.42 % did not identify a race category. Of the 737 intramural research protocols following the current 1997 OMB standards designating an ethnicity in FY 2005, 95.58 % of total participants identified as "Not Hispanic", 2.10 % of the total participants identified as "Hispanic or Latino", and 2.32 % of the total participants did not identify an ethnicity category. The racial distribution of the "Hispanic or Latino" participants is also provided separately. (See 2006 Report, Appendix 7A)

Correspondingly, in FY2006 there were 1,798 intramural clinical research protocols, including Phase III and other clinical studies, of which 1,523 protocols reported human subject participation. Approximately 1.8 million participants were enrolled in intramural research protocols of which 55.4% were women, 43.0% were men and 1.6% did not provide sex identification. (See Table 2 and Appendix Table 7A)

In FY 2006, approximately 1.8 million participants were reported in all intramural research including Phase III clinical trials, and other clinical studies. Of the 590 intramural research protocols that report data following the 1977 OMB standards, minority representation was highest for Asian/Pacific Islanders at 19.9% and lowest for American Indian/Alaska Natives at 3.3%. Blacks (not-Hispanic) represented 7.2%, Hispanics 3.5%; and Whites (not Hispanic) 62.0% of the intramural research study population. The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards. (See Appendix Table 7A)

For 933 intramural clinical research studies that reported data following the current 1997 OMB standards in FY 2006, the largest racial minority group was Asian at 8.6 % and the smallest racial minority group was Hawaiian/Pacific Islanders at 0.07%. Blacks represented 5.0%, American Indian/Alaska Natives 0.4% and Whites 79.1% of participants in all intramural clinical research. Approximately 0.8% of participants reported More Than One Race as their racial category. In addition, 6.0 % did not identify a race category. Of the 933 intramural research protocols following the current 1997 OMB standards designating an ethnicity in FY2006, 91.3 % of total participants identified as "Not Hispanic", 4.1 % of the total participants identified as "Hispanic or Latino", and 4.6 % of the total participants did not identify an ethnicity category. The racial distribution of the "Hispanic or Latino" participants is also provided separately. (See Appendix Table 7A)

There was an increase in female participants from 48.7% to 55.4% and a corresponding decrease in male participants from 50.5% to 43.0%. The number of participants in all intramural clinical research decreased slightly from 1.9M to 1.8M from FY2005 to FY2006.

NIH Defined Phase III Intramural Clinical Research: FY2005 and FY2006
In FY2005, there were 44 intramural Phase III clinical research protocols, of which 36 protocols reported human subject participation. Of these, 6% of the total protocols is domestic protocols and 0.5% of the total protocols is foreign protocols. Approximately 27,044 participants were enrolled in intramural Phase III research protocols of which 2.86% of total enrollment is domestic participation and 2.6% of total enrollment is foreign participation. Of the 27,044 participants, 50.5% were women, 49.5% were men and 0% did not provide sex identification. Further, 54.5% of the total participants in Phase III clinical research were reported as minorities following the OMB categories for race and ethnicity. (See 2006 Report, Table 4 and Appendix Table 9A)

Correspondingly, in FY2006 there were 53 intramural Phase III clinical research protocols, of which 44 protocols reported human subject participation. Of these, 6.3% of the total number of protocols is domestic and 0.7% of the total number of protocols is foreign. Approximately 31,476 participants were enrolled in intramural Phase III research protocols of which 2.34% of the total enrollment is domestic participants and 3.5% are foreign participants. Of the 31,476 participants, 54% were women, 46% were men and 0% did not provide sex identification. Further, 54% of total participants in Phase III clinical research protocols were reported as minorities following the OMB categories for race and ethnicity. (Table 4 and Appendix Table 9A)

There was a small increase in women (50.5% to 54.0%) and corresponding decrease in men (49.5% to 46.0%). The number of participants in Phase III intramural clinical research increased from 27,044 to 31,476.

TREND REPORT ON NIH AGGREGATE POPULATION DATA: FY 1995 – FY 2006


The following section is a new addition to the Annual Comprehensive report. Tables 5-11 provide trend data on the collection and reporting of human subject participation in NIH funded clinical research, which includes Phase III clinical studies; trend data are also provided in terms of foreign and domestic participation. Trend data vary over time because the data for each year represent the net total of data resulting from: (1) studies continuing from the prior year; (2) the addition of new studies reported; and (3) the subtraction of studies that are no longer reported.

Table 5 is a twelve year summary report showing a steady increase in the number of protocols and enrollment. The number of protocols with enrollment increased from 3,188 in FY1995 to 10,758 in FY2006 – a 3.4 fold increase. Reported enrollment increased from approximately 1.0 million (FY1995) to 14.8 million (FY2006) – a 14.5 fold increase; minority enrollment increased from approximately 0.4 million (FY2002) to 6.4 million (FY2006) – a 17.1 increase in minority representation in NIH clinical research. Over the last five years, the total number of protocols reported with enrollment data has leveled off at about 10,000 protocols per year.

With the deployment of a new population tracking system in 2002 and the requirement to report data using a new format, NIH was able to report domestic and foreign data in a better way. Thus, trend data are now available for domestic and foreign protocols and participation beginning in FY2002. Domestic enrollment increased from 10.2 million (FY2002) to 11.4 million (FY2006) – a 1.1 fold increase. Foreign enrollment increased from 0.9 million (FY2002) to 3.4 million (FY2006) – a 3.6 fold increase. Overall, the total enrollment has increased with domestic participation averaging between 75.9-91.5% and foreign participation averaging between 8.5-24.1%. In FY2006, domestic and foreign enrollment was 77.0% and 23.0% respectively.

Table 6 is a summary report of all extramural and intramural clinical research by sex/gender and minority representation following the old and new data formats for domestic and foreign studies. The report demonstrates that female participation in all extramural and intramural research generally averaged between 51.7% and 63.9%, male participation in all extramural and intramural research averaged between 34.9% and 45.0%. Overall minority participation in all extramural and intramural clinical research averaged between 31% and 43%. Table 6E provides a comparison of domestic and foreign participation between FY2002 and FY2006. The vast majority of protocols are domestic (~94%-96%) of the total clinical research protocols. While the number of foreign protocols has increased, they incorporate only about 4%-6% of the total clinical research protocols with enrollment. Table 6F shows domestic and foreign enrollment for the five-year period. Domestic minority enrollment varied between 24.1% and 28.9% of total domestic participation, while foreign minority enrollment varied between 82.2% and 90.9% of total foreign participation.

Table 7 is a summary report of NIH-funded Phase III extramural and intramural clinical research by sex/gender and minority representation following the old and new data reporting formats for domestic and foreign studies. The report demonstrates that female participation in NIH funded Phase III extramural and intramural clinical research generally averaged between 54.1% and 74.8% and male participation in NIHfunded Phase III extramural and intramural clinical research averaged between 24.3% and 44.6%. Overall minority participation in NIH-funded Phase III extramural and intramural clinical research increased from 26.9% to 33.5%. Table 7E provides a comparison of domestic and foreign participation between FY2002 and FY2006. The vast majority of protocols are domestic (75.5% and 95.8%) of the total clinical research protocols. While the number of foreign protocols has decreased, they incorporate only about 4.2%-9.6% of the total clinical research protocols with enrollment in the last three years. Table 7F shows domestic and foreign enrollment for the five-year period. Domestic minority enrollment varied between 20.7% and 25.4% of total domestic participation, while foreign minority enrollment in NIH-funded Phase III clinical research varied between 48.4% and 85.2% of total foreign participation. Comparing both domestic and foreign Phase III enrollment over the five year period shows that the small percentage of foreign protocols(9.6%) in FY2006 account for a significant proportion (19.8%) of the total enrollment.

Tables 8-11 provide summary reports of domestic and foreign participation for NIH funded clinical research and NIH-funded Phase III clinical research. For extramural and intramural clinical research, domestic participants enrolled in domestic protocols, female participation averaged between 61.8 and 67.3% while male participation averaged between 31.2 and 36.9%. (Table 8) For NIH-funded Phase III extramural and intramural clinical research, domestic participants enrolled in domestic protocols, female participation averaged between 54.8 and 64.6% while male participation averaged between 34.4 and 44.8%. (Table 9) For all extramural and intramural clinical research, foreign participants enrolled in foreign protocols, female participation varied from 39.2% to 58.5% while male participation varied from 40.1% to 60.4%. (Table 10) For NIH-funded Phase III extramural and intramural clinical research, foreign participants enrolled in foreign protocols, female participation varied from 47.4% to 56.7% while male participation varied from 42.0% to 52.5%. (Table 11)


Table 1. Summary of NIH Clinical Research Reported In FY2006: Total Number of Protocols and Enrollment By Sex and Domestic versus Foreign Protocols

1A. Protocols Reported Total All Clinical
Studies*
Domestic % Foreign %
Protocols with Enrollment 10,758 10,294 95.7% 464 4.3%
% 70.2% 70.3%   69.3%  
Protocols with zero enrollment.
Enrollment data has not yet been
submitted
4,562 4,356 95.5% 206 4.5%
  29.8% 29.7%   30.7%  
Total Number of Protocols 15,320 14,650 95.6% 670 4.4%
% 100.0% 100.0%   100.0%  

1B. Enrollment Reported Total All Clinical
Studies*
Domestic % Foreign %
Females Enrolled 9,473,273 7,684,453 81.1% 1,788,820 18.9%
% 63.9% 67.3%   52.5%  
Males Enrolled 5,172,205 3,566,577 69.0% 1,605,628 31.0%
% 34.9% 31.2%   47.2%  
Sex of Subjects is Unknown 185,452 174,671 94.2% 10,781 5.8%
% 1.3% 1.5%   0.3%  
Total Subjects Enrolled 14,830,930 11,425,701 77.0% 3,405,229 23.0%
% 100.0% 100.0%   100.0%  

1C. Minority Enrollment Reported Total All Clinical
Studies*
Domestic % Foreign %
Minority Total** 6,388,316 3,301,135 51.7% 3,087,181 48.3%
% Minority Enrollment 43.1% 28.9%   90.7%  


* Clinical research studies include non-intervention clinical research, clinical trials, epidemiologic studies, behavioral studies, database studies, etc., based on the NIH definition of clinical research. “Total All Clinical Studies” includes NIH Defined Phase III Clinical Trials.

** See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997U.S. OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories.

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

Comments

Table 1. Summary of NIH Clinical Research Reported In FY2006: Total Number of Protocols and Enrollment By Sex and Domestic versus Foreign Protocols

Table 1A: Total Number of Protocols

1. The total number of protocols reported in the NIH database in FY2006 was 15,320; of these, 10,758 (70.2%) reported subject enrollment.
2. Subsequent Tables reporting “Enrollment Reported” are based on the 10,758 protocols reporting subject enrollment, or a defined subset.
3. Protocols with zero enrollment (data not yet submitted) are not included in subsequent tables reporting “Enrollment reported.”

Total Domestic Protocols
4. Domestic protocols made up the vast majority of protocols (14,650; 95.6%); of these, 10,294 (70.3%) reported domestic subject enrollment.
5. Clinical Research involving both domestic and foreign sites are reported as separate domestic and foreign protocols in subsequent tables.

Table 1B: Total Enrollment Reported

1. The total “Enrollment Reported” in the NIH database in FY2006 was 14,830,930 subjects in 10,758 protocols with enrollment.
2. Females made up 63.9% (9.5M) of the total subjects enrolled, while Males made up 31.2%(5.2M), with 1.3% unknown.

Total Domestic Enrollment Reported
3. The total Domestic Enrollment reported was 11,425,701 (77%).
4. Females made up 67.3%(7.7M) of the domestic subjects enrolled, while Males made up 31.2%(3.56M), with1.5%(.17M) unknown.

Table 1C Comments: Minority Enrollment Reported

1. Minorities made up 43.1% (6.4M) of the total subjects enrolled.
2. Minorities made up 28.9%(3.3M) of the Domestic Enrollment.
3. The Total Minority Enrollment was made up of 51.7% Domestic and 48.3% Foreign enrollment The small percentage of foreign protocols (4.0%) account for a significant proportion (48.3%) of the total minority enrollment.

Table 2: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2006: Number of Sex-Specific Protocols, and Domestic versus Foreign Protocols

      Domestic Foreign
2A. Protocols Reported   Total All Clinical
Studies
Extramural % Intramural % Extramural % Intramural %
Number of Protocols reporting females only   1,338 1,162 86.8% 124 9.3% 46 3.4% 6 0.4%
%   8.7% 9.0%   7.3%   8.1%   6.1%  
Number of Protocols reporting males only   581 468 80.6% 93 16.0% 17 2.9% 3 0.5%
%   3.8% 3.6%   5.5%   3.0%   3.0%  
Number of Protocols with Both Female
and Male Enrollment (excluding sexspecific
protocols)
  8,839 7,221 81.7% 1,226 13.9% 321 3.6% 71 0.8%
%   57.7% 55.8%   72.2%   56.2%   71.7%  
Total Number of Protocols with
Enrollment
  10,758 8,851 82.3% 1,443 13.4% 384 3.6% 80 0.7%
%   70.2% 68%   84.9%   67.3%   80.8%  
Number of Protocols with zero enrollment. Enrollment data has not yet been submitted.   4,562 4,100 89.9% 256 5.6% 187 4.1% 19 0.4%
%   29.8% 31.7%   15.1%   32.7%   19.2%  
Total Number of Protocols   15,320 12,951 84.5% 1,699 11.1% 571 3.7% 99 0.6%
%   100.0% 100.0%   100.0%   100.0%   100.0%  


      Domestic Foreign
2B. Enrollment Reported   Total All Clinical
Studies*
Extramural % Intramural % Extramural % Intramural %
In Protocols reporting females only   4,120,055 3,678,382 89.3% 202,024 4.9% 115,369 2.8% 124,280 3.0%
%   27.8% 36.9%   13.9%   3.8%   35.0%  
In Protocols reporting males only   336,717 274,774 81.6% 3,294 1.0% 32,552 9.7% 26,097 7.8%
%   2.3% 2.8%   0.2%   1.1%   7.3%  
In Protocols excluding female-only and
male-only enrollment protocols
  10,374,158 6,018,281 58.0% 1,248,946 12.0% 2,902,088 28.0% 204,843 2.0%
%   69.9% 60.4%   85.9%   95.2%   57.7%  
Enrollment Totals for all studies   14,830,930 9,971,437 67.2% 1,454,264 9.8% 3,050,009 20.6% 355,220 2.4%
%   100.0% 100.0%   100.0%   100.0%   100.0%  


      Domestic Foreign
2C. Minority Enrollment Reported**   Total All
Clinical Studies*
Extramural % Intramural % Extramural % Intramural %
Minority Totals for all studies   6,388,316 3,102,731 48.6% 198,404 3.1% 2,878,826 45.1% 208,355 3.3%
% Minority enrollment   43.1% 31.1%   13.6%   94.4%   58.7%  

**See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories.

Comments
Table 2: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2006: Number of Sex- Specific Protocols, and Domestic versus Foreign Protocols

Table 2A Total Number of Protocols with Enrollment

1. Female Only Protocols: There were 1,338 protocols reporting females only, representing 12.4 %(1338/10,758) of protocols with enrollment.
90% were Extramural projects(1,162+46); 10% were NIH intramural projects(124+6).
96% were Domestic protocols(1162+124);4% were Foreign protocols(40+6).
2. Male Only Protocols: There were 581 protocols reporting males only, representing 5%(558/10,758) of protocols with enrollment.
83 % were Extramural projects(468+17); 17% were NIH intramural projects(93+3)
97% were Domestic protocols(468+93); 3 % were Foreign protocols(17+3).
3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were 8,839 protocols reporting both female and male participants representing 82%(8,839/10,758) of the total number of protocols.
85% were Extramural projects(7,221+321); 15% were NIH intramural projects(1,226+71)

Table 2B Total Enrollment Reported

1. In Female Only Protocols: There were approximately 4.1 M females, representing 28% of total enrollment.
92.1% were in Extramural projects; 7.9% were in NIH intramural projects.
94.2% were in Domestic protocols; 5.8% were in Foreign protocols.
2. In Male Only Protocols: There were approximately 336,717 males, representing 2.3% of total enrollment.
91.3% were in Extramural projects; 18.8% were in NIH intramural projects.
82.6% were Domestic in protocols 17.4 % were Foreign protocols.
3. In Protocols Reporting Both Females and Males (excluding sex-specific studies): There were approximately 10,374,158 subjects, representing 70% of total enrollment.
86% were in Extramural projects;14% were in NIH intramural projects. 70% were in Domestic protocols; 30% were in Foreign protocols. 96% were Domestic protocols(7,221+1,226);4% were Foreign protocols(321+71).

Table 2C Minority Enrollment Reported

1. Total Minority Enrollment: 43.1% of Total Enrollment (14.8M).

Total Minority Enrollment, Domestic only: 28.9% (3,301,135/11,425,701)
Total Domestic Minority Enrollment: 51.7% (3,301,135/6,388,316)
Total Foreign Minority Enrollment: 48.3% (3,087,181/6,388,316)
Total Extramural projects Minority enrollment: 40.33% (5,981,557/14,830,930)
Total Intramural Projects Minority enrollment: 2.74% (406,759/14,830,930)


Table 3. Summary of NIH Phase III Clinical Research Reported In FY2006: Total Number of Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols

3A. Protocols Reported Total of Phase III
Clinical Trials*
Domestic % Foreign %
Protocols with Enrollment 624 564 90.4% 60 9.6%
% 82.1% 82.0%   83.3%  
Protocols with zero enrollment. Enrollment
data has not yet been submitted.
136 124 91.2% 12 8.8%
  17.9% 18.0%   16.7%  
Total Number of Protocols 760 688 90.5% 72 9.5%
% 100.0% 100.0%   100.0%  


3B. Enrollment Reported Total of Phase III
Clinical Trials*
Domestic % Foreign %
Females Enrolled 314,066 258,467 82.3% 55,599 17.7%
% 62.9% 64.6%   56.1%  
Males Enrolled 179,975 137,621 76.5% 42,354 23.5%
% 36.0% 34.4%   42.7%  
Sex of Subjects is Unknown 5,389 4,209 78.1% 1,180 0.0%
% 1.1% 1.1%   1.2%  
Total Subjects Enrolled 499,430 400,297 80.2% 99,133 19.8%
% 100.0% 100.0%   100.0%  


3C. Minority Enrollment Reported ** Total of Phase III
Clinical Trials*
Domestic % Foreign %
Minority Total for all Phase III studies 167,446 83,034 49.6% 84,412 50.4%
  33.5% 20.7%   85.2%  


* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care.

**See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories.

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.


Comments
Table 3. Summary of NIH Phase III Clinical Research Reported In FY2006: Total Number of Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols.


Table 3A Total Number of Protocols
1. The total number of NIH defined Phase III Clinical protocols reported in the NIH database in FY2006 was 760; of these, 624(82.1%) reported subject enrollment.
2. Subsequent Tables reporting “Enrollment Reported” are based on the 624 protocols reporting subject enrollment, or a defined subset.
3. Protocols with zero enrollment (data not yet submitted) are not included in subsequent tables reporting “Enrollment reported.”

Total Domestic Protocols
4. Domestic protocols made up the vast majority of protocols (688; 90.5%); of these 564(82%) reported domestic subject enrollment.
5. Clinical Research involving both domestic and foreign sites are reported as separate domestic and foreign protocols in subsequent tables.

Table 3B: Total Enrollment Reported
1. The total “Enrollment Reported” in NIH Defined Phase III Protocols in the NIH database in FY2006 was 499,430 subjects in 624 protocols.
2. Females made up 62.9% (314,068) of the total subjects enrolled, while Males made up 36.0%(179,975), with 1.1%(5,389) unknown.
3. Minorities made up 33.5% (167,446) of the total subjects enrolled.

Total Domestic Enrollment Reported
4. The total Domestic Enrollment reported was 400,297(80.2%).
5. Females made up 64.6%(258,467) of the domestic subjects enrolled, while Males made up 34.4%(137,621), with 1.1%(4,209) unknown.

Table 3C Comments: Minority Enrollment Reported
1. Minorities made up 33.5% of total subjects enrolled.
2. Minorities made up 20.7%(83,034) of the Domestic Enrollment (400,297).
3. The Total Minority Enrollment was made up of 49.6% Domestic and 50.4% Foreign enrollment.


Table 4: Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2006: Number of Sex-Specific Protocols and Enrollment, and Domestic versus Foreign Protocols

      Domestic Foreign
4A. Protocols Reported   Total All Clinical
Studies*
Extramural % Intramural % Extramural % Intramural %
Number of Protocols reporting females only   118 101 85.6% 2 1.7% 14 11.9% 1 0.8%
%   15.5% 15.8%   4.2%   20.9%   20.0%  
Number of Protocols reporting males only   47 39 83.0% 4 8.5% 4 8.5% 0 0.0%
%   6.2% 6.1%   8.3%   6.0%   0.0%  
Protocols with Both Female and Male
Enrollment (excluding sex-specific
protocols)
  459 384 83.7% 34 7.4% 38 8.3% 3 0.7%
%   60.4% 60.0%   70.8%   56.7%   60.0%  
Total Number of Protocols with
Enrollment
  624 524 84.0% 40 6.4% 56 9.0% 4 0.6%
%   82.1% 82%   83.3%   83.6%   80.0%  
Phase III Protocols with zero enrollment.
Enrollment data has not yet been
submitted.
  136 116 85.3% 8 5.9% 11 8.1% 1 0.0%
%   17.9% 18.1%   16.7%   16.4%   20.0%  
Total Number of Phase III Protocols   760 640 84.2% 48 6.3% 67 8.8% 5 0.7%
%   100.0% 100.0%   100.0%   100.0%   100.0%  


      Domestic Foreign
4B. Enrollment Reported   Total of Phase III Clinical Trials* Extramural % Intramural % Extramural % Intramural %
Protocols reporting female only   167,624 148,185 88.4% 4 0.0% 17,195 10.3% 2240 1.3%
%   33.6% 38.4%   0.0%   21.0%   13.0%  
Protocols reporting male only   27,723 23,312 84.1% 177 0.6% 4,234 15.3% 0 0.0%
%   5.6% 6.0%   1.2%   5.2%   0.0%  
Protocols excluding female-only and men-only enrollment protocols   304,083 214,619 70.6% 14,000 4.6% 60,409 19.9% 15,055 5.0%
%   60.9% 55.6%   98.7%   73.8%   87.0%  
Total Subjects Enrolled   499,430 386,116 77.3% 14,181 2.84% 81,838 16.39% 17,295 3.5%
%   100.0% 100.0%   100.0%   100.0%   100.0%  


      Domestic Foreign
4C. Minority Enrollment Reported**   Total of Phase III Clinical Trials* Extramural % Intramural % Extramural % Intramural %
Minority Total for all Phase III studies   167,624 80,622 48.1% 2,412 1.4% 69,820 41.7% 14,592 8.7%
%   33.5% 20.9%   17.0%   85.3%   84.4%  
* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care.

**See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories.

Comments
Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2006 : Number of Sex-Specific Protocols and Enrollment, and Domestic versus Foreign Protocols

Table 4A Total Number of Protocols with Enrollment

1. Female Only: There were 118 protocols reporting females only, representing 19 % (118/624) of protocols with enrollment, and 15.5% of the Total Number of Protocols.
97% were Extramural projects (115);3% were NIH intramural projects (3).
87% were Domestic protocols (103); 13% were Foreign protocols (15).
2. Male Only: There were 47 protocols reporting males only, representing 8% (47/624) of protocols with enrollment, and 6.2% o the Total Number of Protocols.
91% were Extramural projects (43); 9% were NIH intramural projects (4).
91% were Domestic protocols (43);9% were Foreign protocols (4).
3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were 459 protocols reporting both males and females representing 60.4 % of the total number of protocols.
92.0% were Extramural projects (422); 8.0% were NIH intramural projects (37).
91% were Domestic protocols (418); 9.0% were Foreign protocols (41).

Table 4B Total Enrollment Reported

1. In Female Only Protocols: There were approximately 167,624 females, representing 33.6% of total enrollment.
98.7% (165,380) were in Extramural projects; 1.3% (2,244) were in NIH intramural projects.
88.4% (148,189) were in Domestic protocols; 11.67% (19,435) were in Foreign protocols.
2. In Male Only Protocols: There were approximately 27,723 males, representing 5.6% of total enrollment.
99.4% (27,546) were in Extramural projects; 0.6% (177) were in NIH intramural projects.
84.7% (23,489) were in Domestic protocols; 15.3% (4,234) were in Foreign protocols.
3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were approximately 304,083 subjects, representing 60.9% of total enrollment.
90.45% (275,028) were in Extramural projects; 9.55% (29,055) were in NIH intramural projects.
75.2% (228,619) were in Domestic protocols; 24.8% (75,464) were in Foreign protocols.


Table 4C Minority Enrollment Reported

1. Total Minority Enrollment was 33.5% (167,446) of Total Enrollment (499,430).
Total Minority enrollment, Extramural protocols (150,442), was 30.12% of Total Enrollment (499,430) and 89.9% of Total Minority Enrollment (167,446).
Total Minority enrollment, Intramural Projects (17,004), was 3.4% of Total Enrollment (499,430) and 10.15% of Total Minority Enrollment (167,446).
2. Total Minority Enrollment, Domestic only (83,034), was 20.7% of total Domestic Enrollment (400,297) and 49.6% of Total Minority Enrollment (167,446).
3. Total Minority Enrollment, Foreign (84,412), was 85.15% of Total Foreign Enrollment (99,133) and 50.4% of Total Minority Enrollment (167,446).

5A. Twelve Year Increases in Protocols and Enrollment Data
FY Reported 1995   2006 Relative Increase,
2006 / 1995
Total Protocols with Enrollment 3,188   10,758 3.4
Total Enrollment 1,021,493   14,830,930 14.5
Total Minorities 374,433   6,388,316 17.1
% of Minority 36.7%   43.1% 1.2
 
FY Reported 2002   2006 Relative Increase 2006 / 2002
Total DOMESTIC Enrollment data 10,192,401   11,425,701 1.1
Total FOREIGN Enrollment 946,083   3,405,229 3.6


Table 5A Comments:

1. There was a 3.4 fold increase in protocols with enrollment reported from 1995 to 2006, from 3,188 protocols to 10,758 protocols.
2. There was a 14.5 fold increase in enrollment reported from 1995 to 2006, from approximately 1M to 15 M.
3. There was a 17.1 fold increase in minority enrollment from 1995 to 2006, from approximately 0.4 M to 6.4 M.
4. Domestic and Foreign data were reported for FY 2002-2006, and showed 1.1 fold increase in domestic enrollment (from 10.2M to 11.4M) and a 3.6 fold increase in foreign enrollment (from 0.95M to 3.4M).
5. See Table 6 for 12 year enrollment totals 1995-2006.

*NOTE: Trend data varies over time because the data for each year represent the net toal of data resulting from (1) studies continuing from the prior year; (2) the addition of new studies reported and (3) the subtraction of studies that are no longer reported.

 
5B. Twelve Year Summary of Total Number of Protocols Reported: FY 1995-2006
FY Reported FY Funded Number of Protocols
with Enrollment
data (Old +New Forms):
Number of DOMESTIC
Protocols with
Enrollment data
Number of
FOREIGN Protocols with Enrollment data
Percent
Domestic
Protocols
Protocol
Form*
1995 1994 3,188       OLD
1996 1995 6,036      
1997 1996 5,692      
1998 1997 7,602      
1999 1998 8,285      
2000 1999 9,390      
2001 2000 10,212      
 
2002 2001 8,945 8,463 482 94.6% Old + New
2003 2002 10,216 9,578 638 93.8%
2004 2003 10,125 9,760 365 96.4%
2005 2004 10,233 9,862 371 96.4%
2006 2005 10,758 10,294 464 95.7%




Table 5B Comments:

1. Table 5B and 5B Graph provide the number of OLD and NEW protocols year by year (1995-2006) and the distribution between domestic and foreign protocols for years 2002-2006.
2. The total number of protocols reported with enrollment have leveled off at about 15,000 over the last 4 years.
3. The vast majority of protocols were for domestic studies for 2002-2006, ranging from 93.8% to 96.4% of protocols.

* Data have been reported using a combined race/ethnicity format (OLD FORM) since 1995. New protocols began reporting separate race and ethnicity data in FY2002 (NEW FORM). During 2002-2006, data have been reported using both Old and New Forms.

*See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories.


5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2006
FY Reported FY Funded Total Enrollment data (Old +NewForms): Total DOMESTIC
Enrollment data
PercentDOMESTIC
Enrollment
Total FOREIGN
Enrollment
Percent
FOREIGNEnrollment
2002 2001 11,138,484 10,192,401 91.5% 946,083 8.5%
2003 2002 14,772,254 11,911,357 80.6% 2,860,897 19.4%
2004 2003 18,923,920 14,359,793 75.9% 4,564,127 24.1%
2005 2004 15,722,752 12,669,858 80.6% 3,052,894 19.4%
2006 2005 14,830,930 11,425,701 77.0% 3,405,229 23.0%


Percent Comparison of Domestic and Foreign Enrollment



Table 5C Comments:

1. Overall total enrollment has increased, as well as total domestic and foreign enrollment during the last five years. The percentage of domestic enrollment has decreased to approximately 79% as the foreign enrollment has increased to approximately 21%.



6A. TWELVE YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER AND MINORITY CATEGORIES IN ALL
PROTOCOLS (Old + New Forms)
FY
Reported
FY
Funded
Form Females Males Unknown Total All
Subjects (Old
+ New
Forms)
Subtotal: All Subjects
Enrolled by US Minority
Categories
Number of
Protocols with
Enrollment
data (Old +
New Forms):
1995 1994 Old 528,421 459,921 33,151 1,021,493 374,433 3,188
  %   51.7% 45.0% 3.2% 100.0% 36.7%  
1996 1995 Old 4,130,385 2,583,865 91,054 6,805,304 2,125,958 6,036
  %   60.7% 38.0% 1.3% 100.0% 31.2%  
1997 1996 Old 3,320,610 1,930,783 65,540 5,316,933 1,709,223 5,692
  %   62.5% 36.3% 1.2% 100.0% 32.2%  
1998 1997 Old 4,246,130 2,716,880 115,566 7,078,576 2,923,662 7,602
  %   60.0% 38.4% 1.6% 100.0% 41.3%  
1999 1998 Old 5,102,306 2,712,068 169,863 7,984,237 3,108,228 8,285
  %   63.9% 34.0% 2.1% 100.0% 38.9%  
2000 1999 Old 5,585,042 3,919,065 64,990 9,569,097 3,406,297 9,390
  %   58.4% 41.0% 0.7% 100.0% 35.6%  
2001 2000 Old 6,808,822 4,740,887 44,547 11,594,256 3,619,119 10,212
  %   58.7% 40.9% 0.4% 100.0% 31.1%  
2002 2001 Old + New 7,155,549 3,904,560 78,375 11,138,484 3,666,880 8,945
  %   64.2% 35.1% 0.7% 100% 32.9%  
2003 2002 Old + New 8,514,481 6,121,496 136,277 14,772,254 5,387,692 10,216
  %   57.6% 41.4% 0.9% 100.0% 36.5%  
2004 2003 Old + New 10,889,097 7,741,892 292,931 18,923,920 7,611,611 10,125
  %   57.5% 40.9% 1.5% 100.0% 40.2%  
2005 2004 Old + New 9,503,922 5,941,907 276,923 15,722,752 6,245,436 10,233
      60.4% 37.8% 1.8% 100.0% 39.7%  
2006 2005 Old + New 9,473,273 5,172,205 185,452 14,830,930 6,388,316 10,758
      63.9% 34.9% 1.25% 100.0% 43.1%  




Total Minority Enrollment by Year Reported

   

Sex/Gender Enrollment by Year Reported


 

Table 6A Comments:

1. Table 6A summarizes enrollment by sex/gender and minority race/ethnicity categories for the twelve year reporting period (1995-2006). The data are compiled from Tables 6B, 6C and 6D below, which provide the detailed distributions by sex/gender and race/ethnicity using the OLD Enrollment Form (Table 6B) and the NEW Enrollment Form (Tables 6C and 6D).

2. The Race and Ethnicity data in the OLD FORM and the NEW FORM cannot be combined by individual race and ethnicity categories because the categories reflect the different OMB Formats used based on the 1977 OMB standards (OLD FORM) and the 1997 OMB Standards (NEW FORM).

NOTE: Trend data varies over time because the data for each year represent the net total of data resulting from:(1) studies continuing from the prior year; (2) the addition of new studies reported; (3) and the subtraction of studies that are no longer reported.



Notes Tables B-D

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data.

NOTE 2: Data from Tables 6B, 6C and 6D are combined to provide the summary data in Table 6A.

6B. OLD FORM: Total of All Subjects Reported Using the 1977 OMB Standards in a Combined Race/Ethnicity Format
FY Reported FY Funded American Indian/
Alaska Native
Asian/ Pacific
Islander
Black or African
American
Hispanic,
Not White
White Unknown/Ot
her
Total Subtotal Using US Minority Categories
shaded): OLD FORM
Number
Protocols with
Enrollment data
(Old Form):
1995 1994 11,221 38,952 234,976 89,284 540,313 106,747 1,021,493 374,433 3,188
  % 1.1% 3.8% 23.0% 8.7% 52.9% 10.5% 100.0% 36.7%  
1996 1995 146,319 617,211 823,102 539,326 4,114,249 565,097 6,805,304 2,125,958 6,036
  % 2.2% 9.1% 12.1% 7.9% 60.5% 8.3% 100.0% 31.2%  
1997 1996 36,638 321,479 864,102 487,004 3,199,778 407,932 5,316,933 1,709,223 5,692
  % 0.7% 6.0% 16.3% 9.2% 60.2% 7.7% 100.0% 32.1%  
1998 1997 71,436 1,429,022 1,081,210 526,560 4,470,966 405,043 7,984,237 3,108,228 8,285
  % 1.2% 17.5% 15.5% 7.1% 52.5% 6.2% 100.0% 41.3%  
1999 1998 71,436 1,429,022 1,081,210 526,560 4,470,966 405,043 7,984,237 3,108,228 8,285
  % 0.9% 17.9% 13.5% 6.6% 56.0% 5.1% 100.0% 38.9%  
2000 1999 82,728 1,525,392 1,209,769 588,408 5,588,942 573,858 9,569,097 3,406,297 9,390
  % 0.9% 15.9% 12.6% 6.1% 58.4% 6.0% 100.0% 35.6%  
2001 2000 105,067 1,495,279 1,199,625 819,148 7,314,449 660,688 11,594,256 3,619,119 10,212
  % 0.9% 12.9% 10.3% 7.1% 63.1% 5.7% 100.0% 31.2%  
 
2002 2001 45,843 1,222,296 702,234 398,657 4,044,052 321,349 6,734,431 2,369,030 6,187
  % 0.7% 18.1% 10.4% 5.9% 60.1% 4.8% 100.0% 35.2%  
2003 2002 36,579 730,542 472,426 288,523 3,238,284 278,901 5,045,255 1,528,070 4,903
  % 0.7% 14.5% 9.4% 5.7% 64.2% 5.5% 100.0% 30.3%  
2004 2003 29,387 307,052 342,188 214,322 2,348,529 172,130 3,413,608 892,949 2,782
  % 0.9% 9.0% 10.0% 6.3% 68.8% 5.0% 100.0% 26.2%  
2005 2004 22,375 254,598 229,615 134,972 1,267,089 102,405 2,011,054 641,560 1,786
  % 1.1% 12.7% 11.4% 6.7% 63.0% 5.1% 100.0% 31.9%  
2006 2005 19,648 131,786 148,948 78,596 883,041 63,231 1,325,250 378,978 1,391
  % 1.5% 9.9% 11.2% 5.9% 66.6% 4.8% 100.0% 28.6%  


ORIENTATION TO TABLES 6C and 6D.

1. The New Form consists of Parts A and B (Tables 6C and 6D) for reporting years 2002-2006. This Form is provided as part of the annual progress report.
2. Table 6C displays the New Form Part A for reporting separate race and ethnicity data.
3. Table 6D displays the New Form Part B, which is the Distribution of Hispanics reported by race, using the totals from the “Hispanic or Latino” column in Part A.


6C. New Form Part A: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity Formats
Total of All Subjects by Race Total of All Subjects by Ethnicity
FY
Reported
FY
Funded
American Indian/
Alaska Native
Asian Black or African
American
Hawaiian
/Pacific
Islander
White More Than
One Race
Unknown
/Other
Total* Not
Hispanic
Hispanic or
Latino**
Unknown
/Not
Reported
Total*
2002 2001 77,734 354,049 547,776 21,636 2,651,541 30,955 720,362 4,404,053 3,071,952 292,429 1,039,672 4,404,053
  % 1.8% 8.0% 12.4% 0.5% 60.2% 0.7% 16.4% 100.0% 69.8% 6.6% 23.6% 100.0%
2003 2002 63,544 2,138,002 960,090 37,569 5,415,710 99,462 1,012,622 9,726,999 8,162,259 611,641 953,099 9,726,999
  % 0.7% 22.0% 9.9% 0.4% 55.7% 1.0% 10.4% 100.0% 83.9% 6.3% 9.8% 100.0%
2004 2003 98,047 4,345,396 1,379,857 54,452 8,065,069 186,241 1,381,250 15,510,312 13,168,842 756,339 1,585,131 15,510,312
  % 0.6% 28.0% 8.9% 0.4% 52.0% 1.2% 8.9% 100.0% 84.9% 4.9% 10.2% 100.0%
2005 2004 292,215 3,046,370 1,358,262 53,286 7,672,890 182,953 1,105,722 13,711,698 11,804,164 773,939 1,133,595 13,711,698
  % 2.1% 22.2% 9.9% 0.4% 56.0% 1.3% 8.1% 100.0% 86.1% 5.6% 8.3% 100.0%
2006 2005 141,567 3,463,202 1,251,339 38,460 7,089,017 321,554 1,200,541 13,505,680 11,308,244 1,054,313 1,143,123 13,505,680
  % 1.0% 25.6% 9.3% 0.3% 52.5% 2.4% 8.9% 100.0% 83.7% 7.8% 8.5% 100.0%
 
6D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos EnrollSeudbt ottoa UDsatgeU (SCumulative)
FY Reported FY Funded American Indian/
Alaska Native
Asian Black or African
American
Hawaiian
/Pacific
Islander
White More Than
One Race
Unknown
/Other
Total Hispanic
or Latino**
Minority Categories
(shaded): NEW FORM
Parts A+B
Number of
Protocols with
Enrollment data
(New Form):
2002 2001 4,867 1,305 13,066 101 159,252 7390 106,448 292,429 1,297,850 2,758
  % 1.7% 0.4% 4.5% 0.0% 54.5% 2.5% 36.4% 100.0% 29.5%  
2003 2002 5,400 1,953 14,566 679 350,439 28,088 210,516 611,641 3,859,622 5,313
  % 0.9% 0.3% 2.4% 0.1% 57.3% 4.6% 34.4% 100.0% 39.7%  
2004 2003 6,408 5,040 25,276 2,037 361,112 62,909 293,557 756,339 6,718,662 7,343
  % 0.8% 0.7% 3.3% 0.3% 47.7% 8.3% 38.8% 100.0% 43.3%  
2005 2004 22,739 7,816 19,446 1,981 388,874 51,166 281,916 773,938 5,603,876 8,447
  % 2.9% 1.0% 2.5% 0.3% 50.2% 6.6% 36.4% 100.0% 40.9%  
2006 2005 45,074 6,641 21,712 2,193 417,495 185,477 375,721 1,054,313 6,009,338 9,367
  % 4.3% 0.6% 2.1% 0.2% 39.6% 17.6% 35.6% 100.0% 44.5%  

* These totals must agree.
**These totals must agree.


6E. Comparison of Domestic and Foreign Enrollment & Protocols with Total Enrollment for the period FY2002-2006
ENROLLMENT PROTOCOLS
FY
Reported
FY
Funded
Total Enrollment
data (Old + New
Forms):
Total DOMESTIC
Enrollment
Percent
DOMESTIC
Enrollment
Total FOREIGN
Enrollment
Percent
FOREIGN
Enrollment
Number of
Protocols
with
Enrollment
data (Old +
New Forms):
Number
of
DOMESTI
C
Protocols
Percent
Domestic
Protocols
Number of
FOREIGN
Protocols
Percent Foreign
Protocols
2002 2001 11,138,484 10,192,401 91.5% 946,083 8.5% 8,945 8,463 94.6% 482 5.4%
2003 2002 14,772,254 11,911,357 80.6% 2,860,897 19.4% 10,216 9,578 93.8% 638 6.2%
2004 2003 18,923,920 14,359,793 75.9% 4,564,127 24.1% 10,125 9,760 96.4% 365 3.6%
2005 2004 15,722,752 12,669,858 80.6% 3,052,894 19.4% 10,233 9,862 96.4% 371 3.6%
2006 2005 14,830,930 311,425,701 77.0% 3,405,229 23.0% 10,758 10,294 95.7% 464 4.3%



Percentage of Domestic and Foreign Enrollment

       

Number of Domestic and Foreign protocols



Table 6 E Comments:

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2006.
2. The Domestic enrollment decreased to approximately 80%, while the Foreign enrollment increased to approximately 20%.
3. The vast majority of protocols are domestic protocols (approximately 94-96%), while foreign protocols make up approximately 4-6% of total protocols.
4. Foreign enrollment was reported using the same race and ethnicity categories as domestic enrollment.

 6F. Comparison of Domestic and Foreign Minority Participation for FY 2002-2006
FY
Reported
FY
Funded
FOREIGN
Minority
Foreign Totalt DOMESTIC
Minorityt
Domestic
Totalt
2002 2001 777,461 946,083 2,754,820 10,149,869
    82.2% 100.0% 27.1% 100.0%
2003 2002 2,452,329 2,860,897 2,935,363 11,911,357
    85.7% 100.0% 24.6% 100.0%
2004 2003 4,147,255 4,561,127 3,464,356 14,359,793
    90.9% 100.0% 24.1% 100.0%
2005 2004 2,776,565 3,052,894 3,468,864 12,669,858
    90.9% 100.0% 27.4% 100.0%
2006 2005 3,087,181 3,405,229 3,301,135 11,425,701
    90.7% 100.0% 28.9% 100.0%
  Number of Minority Participants for FY2002-2005



NOTE MINORITY % WILL NOT ADD TO 100%

   
Percentage Comparison of Domestic Minority Enrollment to Total Domestic Enrollment for FY 2002-2006   Percentage Comparison of Foreign Minority Enrollment to TotalForeign Enrollment for FY 2002-2006

 
     


Table 6 F Comments:

1. Domestic Minority Enrollment has varied from 24.1% to 28.9% of Total Domestic Enrollment. research is done in countries that are within the OMB race and ethnicity origin categories that are included in the summary
2. The Total Minority Enrollment reported in FY2006 was 52% Domestic and 48 % Foreign (see Table 1). The small percentage of foreign protocols account for a significant proportion (48%) of the Total Minority Enrollment, as shown by comparing both domestic and foreign enrollment data.

Table 7: Twelve Year Minority rend Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in FY1995-2006: Enrollment by Race and Ethnicity.

7A. Phase III TWELVE YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER IN ALL PROTOCOLS (Old + New Forms)
FY
Reported
FY
Funded
Females Males Unknown Total All
Subjects
(Old + New
Forms)
Subtotal: All
Subjects Enrolled
by US Minority
Categories
Number of
Protocols with
Enrollment
data (Old +
New Forms):
1995 1994 171,181 108,324 19,818 299,323 80,562 560
  % 57.2% 36.2% 6.6% 100.0% 26.9%  
1996 1995 264,755 203,698 21,210 489,663 110,669 608
  % 54.1% 41.6% 4.3% 100.0% 22.6%  
1997 1996 264,755 203,698 21,210 489,663 110,000 608
  % 54.1% 41.6% 4.3% 100.0% 22.5%  
1998 1997 228,417 74,389 2,705 305,511 69,599 320
  % 74.8% 24.3% 0.9% 100.0% 22.8%  
1999 1998 339,533 163,950 1,446 504,929 141,449 578
  % 67.2% 32.5% 0.3% 100.0% 28.0%  
2000 1999 313,952 180,705 1,086 495,743 120,339 589
  % 63.3% 36.5% 0.2% 100.0% 24.3%  
2001 2000 412,379 168,085 1,273 581,737 117,873 645
  % 70.9% 28.9% 0.2% 100.0% 20.3%  
2002 2001 278,876 195,090 781 474,747 111,269 754
  % 58.7% 41.1% 0.2% 100.0% 23.4%  
2003 2002 294,950 239,403 1,914 536,267 132,302 852
  % 55.0% 44.6% 0.4% 100.0% 24.7%  
2004 2003 301,353 242,913 1,101 545,367 150,456 573
  % 55.3% 44.5% 0.2% 100.0% 27.6%  
2005 2004 290,977 197,300 4,723 493,000 154,191 547
    59.0% 40.0% 1.0% 100.0% 31.3%  
2006 2005 314,066 179,975 5,389 499,430 167,446 624
    62.9% 36.0% 1.1% 100.0% 33.5%  
     
Total Phase III Enrollment by Year Reported   Sex/Gender Phase III Enrollment by Year Reported
     
         



Table 7A Comments:

1. Table7A summarizes enrollment by sex/gender and minority race/ethnicity categories for the twelve year reporting period (1995-2006). The data are compiled from Tables 7B, 7C and 7D below, which provide the detailed distributions by sex/gender and race/ethnicity using the OLD Enrollment Form (Table 7B) and the NEW Enrollment Form (Tables 7C and 7D).

2. The Race and Ethnicity data in the OLD FORM and the NEW FORM cannot be combined by individual race and ethnicity categories because the categories reflect the different OMB Formats used based on the 1977 OMB standards (OLD FORM) and the 1997 OMB Standards (NEW FORM).

NOTE: Trend data varies over time because the data for each year represent the net total of data resulting from:(1) studies continuing from the prior year; (2) the addition of new studies reported; (3) and the subtraction of studies that are no longer reported.



Notes Tables 7B-D

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data.

NOTE 2: Data from Tables 7B, 7C and 7D are combined to provide the summary data in Table 7A.

7B. Phase III OLD FORM: Total of All Subjects Reported Using the 1977 OMB Standards in a Combined Race/Ethnicity Format
FY Reported FY Funded American
Indian/
Alaska
Native
Asian/ Pacific
Islander
Black or
African
American
Hispanic, Not
White
White Unknown
/Other
Total Subtotal Using US Minority Categories (shaded): OLD FORM Number of Foreign
Protocols with
Enrollment data
(Old Form):
1995 1994 5,358 2,740 52,433 20,031 172,773 45,988 299,323 409 560
  % 1.8% 0.9% 17.5% 6.7% 57.7% 15.4% 100.0% 26.9%  
1996 1995 4,235 40,126 46,838 19,470 321,445 57,549 489,663 110,669 608
  % 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0% 22.6%  
1997 1996 4,235 40,126 46,838 19,470 321,445 57,549 489,663 110,669 608
  % 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0% 22.6%  
1998 1997 5,030 5,324 42,805 16,440 229,534 6,378 305,511 69,599 215
  % 1.6% 1.7% 14.0% 5.4% 75.1% 2.1% 100.0% 22.8%  
1999 1998 3,685 20,276 76,921 40,567 336,703 26,777 504,929 141,449 578
  % 0.7% 4.0% 15.2% 8.0% 66.7% 5.3% 100.0% 28.0%  
2000 1999 3,726 24,017 62,512 30,084 335,824 39,580 495,743 120,339 589
  % 0.8% 4.8% 12.6% 6.1% 67.7% 8.0% 100.0% 24.3%  
2001 2000 4,079 11,132 70,110 32,552 422,802 41,062 581,737 117,873 645
  % 0.7% 1.9% 12.1% 5.6% 72.7% 7.1% 100.0% 20.3%  
2002 2001 1,645 20,560 51,991 29,636 315,543 12,228 431,603 103,832 660
  % 0.38% 4.8% 12.0% 6.9% 73.1% 2.8% 100.00% 24.1%  
2003 2002 1,689 20,038 49,255 29,066 337,654 16,615 454,317 100,048 656
  % 0.4% 4.4% 10.8% 6.4% 74.3% 3.7% 100.0% 22.0%  
2004 2003 1,505 18,807 45,285 32,974 265,764 14,050 378,385 98,571 296
  % 0.4% 5.0% 12.0% 8.7% 70.2% 3.7% 100.0% 26.1%  
2005 2004 1,319 17,740 39,402 21,829 231,492 4,507 316,289 80,290 210
  % 0.4% 5.6% 12.5% 6.9% 73.2% 1.4% 100.0% 25.4%  
2006 2005 1,012 16,800 20,355 9,524 175,724 6,348 229,763 47,691 215
  % 0.4% 7.3% 8.9% 4.1% 76.5% 2.8% 100.0% 20.8%  


ORIENTATION TO TABLES 7C and 7D.
1. The New Form consists of Parts A and B (Tables 7C and 7D) for reporting years 2002-2006. This Form is provided as part of the annual progress report.
2. Table 7C displays the New Form Part A for reporting separate race and ethnicity data.
3. Table 7D displays the New Form Part B, which is the Distribution of Hispanics reported by race, using the totals from the “Hispanic or Latino” column in Part A.

7C. Phase III New Form: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity
Total of All Subjects by Race Total of All Subjects by Ethnicity
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Hawaiian/
Pacific
Islander
White More Than One Race Unknown
/Other
Total Not Hispanic Hispanic
or Latino
Unknown/
Not
Reported
Total
2002 2001 159 799 4,647 52 34,654 560 2,273 43,144 36,224 1,629 5,291 43,144
  % 0.37% 1.85% 10.77% 0.12% 80.32% 1.30% 5.27% 100.00% 83.96% 3.78% 12.26% 100.00%
2003 2002 484 2,609 21,641 220 47,869 989 8,138 81,950 64,295 7,831 9,824 81,950
  % 0.6% 3.2% 26.4% 0.3% 58.4% 1.2% 9.9% 100.0% 78.5% 9.6% 12.0% 100.0%
2004 2003 1,396 4,385 43,721 611 106,793 4,419 5,657 166,982 145,742 13,435 7,805 166,982
  % 0.8% 2.6% 26.2% 0.4% 64.0% 2.6% 3.4% 100.0% 87.3% 8.0% 4.7% 100.0%
2005 2004 2,164 9,192 50,338 462 101,238 3,063 10,254 176,711 156,650 10,397 9,664 176,711
  % 1.2% 5.2% 28.5% 0.3% 57.3% 1.7% 5.8% 100.0% 88.6% 5.9% 5.5% 100.0%
2006 2005 4,630 32,360 50,780 535 126,670 4,246 50,446 269,667 202,358 31,034 36,275 269,667
  % 1.7% 12.0% 18.8% 0.2% 47.0% 1.6% 18.7% 100.0% 75.0% 11.5% 13.5% 100.0%


7D. Phase III Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative)
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Hawaiian/P
acific
Islander
White More Than One Race Unknown/Other
Total FSubtotal Using US Minority Categories (shaded): NEW Number of Protocols with Enrollment data(New Form):
2002 2001 49 22 31 4 660 304 560 1,630 7,437 94
  % 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0% 17.2%  
2003 2002 37 70 186 23 2,115 203 5,197 7,831 32,254 196
  % 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0% 39.4%  
2004 2003 269 59 193 26 7,264 3,052 2,572 13,435 54,405 277
  % 2.0% 0.4% 1.4% 0.2% 54.1% 22.7% 19.1% 100.0% 32.6%  
2005 2004 759 42 446 45 3,667 423 5,015 10,397 73,901 337
  % 7.3% 0.4% 4.3% 0.4% 35.3% 4.1% 48.2% 100.0% 41.8%  
2006 2005 2,307 50 720 40 6,872 713 20,332 31,034 119,755 409
  % 7.4% 0.2% 2.3% 0.1% 22.1% 2.3% 65.5% 100.0% 44.4%  

* These totals must agree
** These totals must agree

 

7E. Comparison of Domestic and Foreign Phase III Enrollment and Protocols with Enrollment for the period FY2002-2006
ENROLLMENT PROTOCOLS
FY
Reported
FY
Funded
Total Enrollment
data (Old + New
Forms):
Total DOMESTIC
Percent
DOMESTIC
Total FOREIGN
Percent
FOREIGN
Number of
Protocols with
Enrollment data (Old + New Forms)
Number of
DOMESTIC
Protocols
Percent
Domestic
Protocols
Number of
FOREIGN
Protocols
Percent Foreign
Protocols
2002 2001 474,747 444,436 93.6% 30,311 6.4% 754 582 77.2% 172 22.8%
2003 2002 536,267 486,857 90.8% 49,410 9.2% 852 643 75.5% 209 24.5%
2004 2003 545,367 496,241 91.0% 49,126 9.0% 573 549 95.8% 24 4.2%
2005 2004 493,000 437,902 88.8% 55,098 11.2% 547 517 94.5% 30 5.5%
2006 2005 499,430 400,297 80.2% 99,133 19.8% 624 564 90.4% 60 9.6%




Percentage of Phase III Domestic and Foreign Enrollment

   

Number of Phase III Domestic and Foreign protocols




Table 7 E Comments:

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2006.
2. The Domestic enrollment decreased to approximately 80%, while the Foreign enrollment increased to approximately 20%.
3. The vast majority of protocols in FY2004-2006 are domestic protocols (approximately 90.4-95.8%), while foreign protocols make up approximately 4.2-9.6% of total protocols.
4. Foreign enrollment was reported using the same race and ethnicity categories as domestic enrollment.

7F. Phase III Foreign and Domestic Minority Comparison for FY 2002-2006
FY
Reported
FY
Funded
FOREIGN
Phase III
Minority
FOREIGN
Phase III
Total
DOMESTI
C Phase III
Minority
DOMESTIC
Phase III
Total
2002 2001 18,308 30,311 92,961 444,436
    60.4% 100.0% 20.9% 100.0%
2003 2002 23,927 49,410 109,376 486,857
    48.4% 100.0% 22.5% 100.0%
2004 2003 37,126 49,126 125,813 496,241
    75.6% 100.0% 25.4% 100.0%
2005 2004 44,281 55,098 109,910 437,902
    80.4% 100.0% 25.1% 100.0%
2006 2005 84,412 99,133 83,034 400,297
    85.2% 100.0% 20.7% 100.0%


Number of Minority Participants in Phase III Clinical Studies for FY2002-2006





Table 7 F Comments:

1. Domestic Minority Enrollment has varied from 24.1% to 28.9% of Total Domestic Enrollment.
2. Foreign Minority Enrollment has varied from 82.2% to 90.9% of Total Foreign Enrollment, reflecting that most of the foreign research is done in countries that are within the OMB race and ethnicity origin categories that are included in the summary minority data used in this report.
3. The Total Minority Enrollment reported in FY2006 was 52% Domestic and 48 % Foreign (see Table 1). The small percentage of foreign protocols account for a significant proportion (48%) of the Total Minority Enrollment, as shown by comparing both domestic and foreign enrollment data.

8A. Five Year Summary Totals: Domestic Subjects in Domestic Protocols(Old + New Forms)
FY
Reported
FY
Funded
Females Males Unknown Total
Domestic
Subjects (Old
+ New Forms)
Subtotal: Domestic
Subjects Enrolled by US
Minority Categories
Number of
Domestic
Protocols with
Enrollment
data (Old +
2002 2001 6,583,087 3,506,787 59,995 10,149,869 2,754,820 8,425
  % 64.9% 34.6% 0.6% 100.0% 27.1%  
2003 2002 7,392,404 4,393,496 125,457 11,911,357 2,935,363 9,578
  % 62.1% 36.9% 1.1% 100.0% 24.6%  
2004 2003 8,881,299 5,199,765 278,729 14,359,793 3,464,356 9,760
  % 61.8% 36.2% 1.9% 100.0% 24.1%  
2005 2004 7,887,209 4,515,242 267,407 12,669,858 3,468,864 9,862
  62.3% 35.6% 2.1% 100.0% 27.4%  
2006 2005 7,684,453 3,566,577 174,671 11,425,701 3,301,135 10,294
  67.3% 31.2% 1.5% 100.0% 28.9%  


Table 8A Comments:

1. There were approximately an average of 63% females, 35% males and 2% of unknown sex enrolled in domestic protocols from 2002-2006.
2. There were approximately an average of 27% domestic minority subjects enrolled in domestic protocols from 2002-2006.
3. Total domestic enrollment ranged from 10.1M to 11.5M during these 5 years.
4. The number of domestic protocols increased from 8,425 to 10,294 in 2006.

NOTE on FY2002 Reported Data:
One domestic study had an enrollment of 540,833 subjects (Old Form).
One domestic study had an enrollment of 1,571,305 subjects (Old Form).

NOTE on FY2003 Reported Data:

One domestic study had an enrollment of 800,000 subjects (New Form).
One domestic study had an enrollment of 1,389,920 subjects (New form).
One domestic study had an enrollment of 1,799,820 subjects (New form).

NOTE on FY2004 Reported Data:

One domestic study had an enrollment of 540,833 subjects (New Form).
One domestic study had an enrollment of 800,000 subjects (New Form).
One domestic study had an enrollment of 1,138,302 subjects (New form).
One domestic study had an enrollment of 1,419,475 subjects (New form).
One domestic study had an enrollment of 1,799,820 subjects (New form).

NOTE on FY2005 Reported Data:

One domestic study had an enrollment of 540,833 subjects (New Form).
One domestic study had an enrollment of 800,000 subjects (New Form).
One domestic study had an enrollment of 1,595,620 subjects (New form).
One domestic study had an enrollment of 1,799,820 subjects (New form).

NOTE on FY2006 Reported Data:

One domestic study had an enrollment of 875,010 subjects (New Form).
One domestic study had an enrollment of 1,964,668 subjects (New Form).
One domestic study had an enrollment of 540,833 subjects (New form).
NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data.

NOTE 2: Data from Tables 8B, 8C and 8D are combined to provide the summary data in Table A.


8B. OLD FORM: Total of All Domestic Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity format
FY Reported FY Funded American
Indian/
Alaska
Native
Asian/ Pacific
Islander
Black or
African
American
Hispanic, Not
White
White Unknown
/Other
  Total
Domestic
Enrollment
(Old Form)
Domestic Subtotal
Using US Minority
ategories (shaded):
OLD FORM
  Number of Domestic
rotocols with
Enrollment data
(Old Form):
2002 2001 45,639 752,203 673,726 378,300 3,880,431 316,053   6,046,352 1,849,868   5,783
  % 0.8% 12.4% 11.1% 6.3% 64.2% 5.2%   100.0% 30.6%    
2003 2002 36,238 249,420 455,329 264,336 3,100,815 266,339   4,372,477 1,005,323   4,478
  % 0.8% 5.7% 10.4% 6.0% 70.9% 6.1%   100.0% 23.0%    
2004 2003 28,953 196,647 322,078 194,762 2,273,619 157,464   3,173,523 742,440   2,702
  % 0.9% 6.2% 10.1% 6.1% 71.6% 5.0%   100.0% 23.4%    
2005 2004 22,375 89,119 210,465 126,351 1,245,337 93,239   1,786,886 448,310   1,736
  % 1.3% 5.0% 11.8% 7.1% 69.7% 5.2%   100.0% 25.1%    
2006 2005 19,628 51,701 148,224 74,312 866,683 61,480   1,222,028 293,865   1,361
  % 1.6% 4.2% 12.1% 6.1% 70.9% 5.0%   100.0% 24.0%    


8C. NEW FORM PART A: Inclusion Enrollment Report (Total of All Domestic Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity Formats)
Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race
Total of All Subjects by Race Total of All Subjects by Ethnicity
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White More Than One Race Unknown
or Not
Reported
*Total of All
Subjects by Racial Categories
(New Form)
Not Hispanic **Hispanic or
Latino
Unknown/
Not
Reported
*Total of All
Subjects by
Ethnic
Category
2002 2001 74,593 174,215 473,699 7,623 2,626,547 30,200 716,640 4,103,517 2,785,590 285,921 1,032,006 4,103,517
  % 1.8% 4.2% 11.5% 0.2% 64.0% 0.7% 17.5% 100.0% 67.9% 7.0% 25.1% 100.0%
2003 2002 61,526 295,061 897,518 23,068 5,161,965 94,138 1,005,604 7,538,880 6,003,326 602,018 933,536 7,538,880
  % 0.8% 3.9% 11.9% 0.3% 68.5% 1.2% 13.3% 100.0% 79.6% 8.0% 12.4% 100.0%
2004 2003 97,854 485,137 1,280,129 42,945 7,772,927 172,185 1,335,093 11,186,270 8,893,158 720,551 1,572,561 11,186,270
  % 0.9% 4.3% 11.4% 0.4% 69.5% 1.5% 11.9% 100.0% 79.5% 6.4% 14.1% 100.0%
2005 2004 291,044 655,959 1,232,957 42,993 7,485,193 164,096 1,010,730 10,882,972 9,120,293 721,138 1,041,541 10,882,972
  % 2.7% 6.0% 11.3% 0.4% 68.8% 1.5% 9.3% 100.0% 83.8% 6.6% 9.6% 100.0%
2006 2005 111,048 946,613 1,032,199 35,142 6,844,960 178,275 1,055,436 10,203,673 8,384,360 796,556 1,022,757 10,203,673
  % 1.1% 9.3% 10.1% 0.3% 67.1% 1.7% 10.3% 100.0% 82.2% 7.8% 10.0% 100.0%


8D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative)
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White (Hispanic) More Than One Race Unknown
or Not
Reported
**Total of
Hispanics or
Latinos by
Racial
Categories
Domestic Subtotal Using US Minority Categories (shaded):NEW FORM Parts A+B Number of
Domestic
Protocols with Enrollment data (New Form):
2002 2001 1,163 436 12,005 98 69,313 5,626 75,309 163,950 904,952 2,642
  % 0.7% 0.3% 7.3% 0.1% 42.3% 3.4% 45.9% 100.0% 22.1%  
2003 2002 3,756 1,950 13,345 678 349,844 23,560 208,885 602,018 1,930,040 5,100
  % 0.6% 0.3% 2.2% 0.1% 58.1% 3.9% 34.7% 100.0% 25.6%  
2004 2003 6,293 5,026 12,498 2,037 356,575 51,031 287,091 720,551 2,721,916 7,058
  % 0.9% 0.7% 1.7% 0.3% 49.5% 7.1% 39.8% 100.0% 24.3%  
2005 2004 22,057 7,810 19,282 1,981 362,707 36,503 270,798 721,138 3,020,554 8,126
  % 3.1% 1.1% 2.7% 0.3% 50.3% 5.1% 37.6% 100.0% 27.8%  
2006 2005 15,498 6,540 19,870 1,505 374,830 49,150 329,163 796,556 3,007,270 8,933
  % 1.9% 0.8% 2.5% 0.2% 47.1% 6.2% 41.3% 100.0% 29.5%  

* These Totals must agree
**These totals must agree


9A . Phase III Five Year Summary Totals: Domestic Subjects In Domestic Protocols(Old + New Forms)
FY Reported FY Funded Females Males Unknown
Total
DomesticSubjects
(Old + New Forms)
Subtotal: Domestic
Subjects Enrolled by
US Minority
Categories
Number of Domestic
Protocols with
Enrollment data
(Old + New Forms):
2002 2001 264,517 179,179 740 444,436 92,961 582
  % 59.5% 40.3% 0.2% 100.0% 20.9%  
2003 2002 266,913 218,166 1,778 486,857 109,376 643
  % 54.8% 44.8% 0.4% 100.0% 22.5%  
2004 2003 277,333 217,890 1,018 496,241 125,813 549
  % 55.9% 43.9% 0.2% 100.0% 25.4%  
2005 2004 261,589 174,137 2,176 437,902 109,910 517
    59.7% 39.8% 0.5% 100.0% 25.1%  
2006 2005 258,467 137,621 4,209 400,297 83,034 564
    64.6% 34.4% 1.1% 100.0% 20.7%  


Table 9A Comments:

  1. There were approximately an average of 57% females, 42% males and 0.3% of unknown sex enrolled in domestic protocols from 2002-2005.
  2. There were approximately an average of 23.5% domestic minority subjects enrolled in domestic Phase III protocols from 2002-2006.
  3. Total domestic Phase III enrollment ranged from 400,297to 496,241 during these 5 years.
  4. The number of domestic Phase III protocols ranged from 517 to 564 in 2006.


NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data.

NOTE 2: Data from Tables 9B, 9C and 9D are combined to provide the summary data in Table A.


9B. OLD FORM: Total of All Domestic Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity format
FY Reported FY Funded American
Indian/
Alaska
Native
Asian/ Pacific
Islander
Black or
African
American
Hispanic, Not
White
White Unknown
/Other
Total
Domestic
Enrollment
(Old Form)
Domestic Subtotal
Using US Minority
Categories (shaded):
OLD FORM
Number of Domestic
Protocols with
Enrollment data
(Old Form):
2002 2001 1,586 8,291 49,184 27,912 305,964 10,670 403,607 86,973 494
  % 0.4% 2.1% 12.2% 6.9% 75.8% 2.6% 100.0% 21.5%  
2003 2002 1,612 7,610 48,975 25,567 322,600 8,538 414,902 83,764 468
  % 0.4% 1.8% 11.8% 6.2% 77.8% 2.1% 100.0% 20.2%  
2004 2003 1,504 6,739 45,233 31,967 262,671 6,447 354,561 85,443 286
  % 0.4% 1.9% 12.8% 9.0% 74.1% 1.8% 100.0% 24.1%  
2005 2004 1,319 5,488 39,401 20,646 229,235 4,493 300,582 66,854 205
  % 0.4% 1.8% 13.1% 6.9% 76.3% 1.5% 100.0% 22.2%  
2006 2005 996 4,505 20,325 9,512 171,191 5,673 212,202 35,338 207
  % 0.5% 2.1% 9.6% 4.5% 80.7% 2.7% 100.0% 16.7%  


9C. NEW FORM Part A: Inclusion Enrollment Report (Total of All Domestic Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity Formats)
Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race
Total of All Subjects by Race Total of All Subjects by Ethnicity
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White More Than One Race Unknown
or Not
Reported
*Total of All
Subjects by Racial Categories
(New Form)
Not Hispanic **Hispanic or
Latino
Unknown/
Not
Reported
*Total of All
Subjects by
Ethnic
Category
2002 2001 159 798 3,199 52 34,541 560 1,520 40,829 34,662 1,629 4,538 40,829
  % 0.4% 2.0% 7.8% 0.1% 84.6% 1.4% 3.7% 100.0% 84.9% 4.0% 11.1% 100.0%
2003 2002 477 2,586 14,031 220 46,774 989 6,878 71,955 55,575 7,828 8,552 71,955
  % 0.7% 3.6% 19.5% 0.3% 65.0% 1.4% 9.6% 100.0% 77.2% 10.9% 11.9% 100.0%
2004 2003 1,396 4,373 22,307 611 106,260 1,849 4,884 141,680 123,770 10,863 7,047 141,680
  % 1.0% 3.1% 15.7% 0.4% 75.0% 1.3% 3.4% 100.0% 87.4% 7.7% 5.0% 100.0%
2005 2004 1,775 4,920 24,390 462 93,662 3,063 9,048 137,320 118,528 9,773 9,019 137,320
  % 1.3% 3.6% 17.8% 0.3% 68.2% 2.2% 6.6% 100.0% 86.3% 7.1% 6.6% 100.0%
2006 2005 2,724 5,312 23,267 530 118,577 4,077 33,608 188,095 141,688 13,550 32,857 188,095
  % 1.4% 2.8% 12.4% 0.3% 63.0% 2.2% 17.9% 100.0% 75.3% 7.2% 17.5% 100.0%


9D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White (Hispanic) More Than One Race Unknown
or Not
Reported
**Total of
Hispanics or
Latinos by
Racial
Categories
Domestic Subtotal Using US Minority Categories (shaded): NEW FORM Parts A+B Number of
Domestic
Protocols with Enrollment data (New Form):
2002 2001 49 21 31 4 660 304 560 1,629 5,988 88
  % 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0% 14.7%  
2003 2002 37 70 186 23 2,113 203 5,196 7,828 25,612 175
  % 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0% 35.6%  
2004 2003 269 59 193 26 7,262 482 2,572 10,863 40,370 263
  % 2.5% 0.5% 1.8% 0.2% 66.9% 4.4% 23.7% 100.0% 28.5%  
2005 2004 371 42 446 45 3,663 423 4,783 9,773 43,056 312
  % 3.8% 0.4% 4.6% 0.5% 37.5% 4.3% 48.9% 100.0% 31.4%  
2006 2005 458 47 507 40 5,544 712 6,242 13,550 47,696 357
  % 3.4% 0.3% 3.7% 0.3% 40.9% 5.3% 46.1% 100.0% 25.4%  

* These totals must agree
** These totals must agree





10A . FIVE YEAR SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN PROTOCOLS (Old + New Forms)
FY Reported FY Funded Females Males Unknown
Total
Domestic Subjects
(Old + New Forms)
Subtotal: Domestic
Subjects Enrolled by
US Minority
Categories
Number of Domestic
Protocols with
Enrollment data
(Old + New Forms):
2002 2001 553,056 379,294 13,833 946,083 777,461 482
  % 58.5% 40.1% 1.5% 100.0% 82.2%  
2003 2002 1,122,077 1,728,000 10,820 2,860,897 2,452,329 638
  % 39.2% 60.4% 0.4% 100.0% 85.7%  
2004 2003 2,007,798 2,542,127 14,202 4,564,127 4,147,255 365
  % 44.0% 55.7% 0.3% 100.0% 90.9%  
2005 2004 1,616,713 1,426,665 9,516 3,052,894 2,776,565 371
  % 53.0% 46.7% 0.3% 100.0% 90.9%  
2006 2005 1,788,820 1,605,628 10,781 3,405,229 3,087,181 464
  % 52.5% 47.2% 0.3% 100.0% 90.7%  


Table 10A Comments:

1. The percent females varied from 39.2% to 58.5% in foreign protocols from 2002-2005; the percent males varied from
40.1% to 60.4%.
2. The percent foreign subjects enrolled by U.S. Minority Categories in foreign protocols increased from 82.2% to 90.9% from 2002 to 2005.
3. Total foreign enrollment ranged from 777,461 to 4.15M during these 5 years.
4. The number of foreign protocols ranged from 638 in 2003 to 317 in 2005.

NOTE on FY2002 Reported Data:
One study in Vietnam had an enrollment of 302,381 subjects (Old Form).

NOTE on FY2003 Reported Data:
One study in Vietnam had an enrollment of 302,381 subjects (Old Form).
One study in China had an enrollment of 1,910,000 subjects (New form).

NOTE on FY2004 Reported Data:
One study in India had an enrollment of 2,000,000 subjects (New Form).
One study in China had an enrollment of 1,910,000 subjects (New form).

NOTE on FY2005 Reported Data:
One study in India had an enrollment of 2,200,000 subjects (New Form).

NOTE on FY2006 Reported Data:
One study in India had an enrollment of 2,200,000 subjects (New Form).



NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data.

NOTE 2: Data from Tables 10B, 10C and 10D are combined to provide the summary data in Table A.

10B.OLD FORM: Total of All FOREIGN Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity format
FY Reported FY Funded American
Indian/
Alaska
Native
Asian/ Pacific
Islander
Black or
African
American
Hispanic, Not
White
White Unknown
/Other
Total
Foreign
Enrollment
(Old Form)
Foreign Subtotal
Using US Minority
Categories (shaded):
OLD FORM
Number of Domestic
Protocols with
Enrollment data
(Old Form):
2002 2001 69 468,958 21,407 19,075 143,768 3,565 656,842 509,509 380
  % 0.0% 71.4% 3.3% 2.9% 21.9% 0.5% 100.0% 77.6%  
2003 2002 341 481,122 17,097 24,187 137,469 12,562 672,778 522.747 425
  % 0.1% 71.5% 2.5% 3.6% 20.4% 1.9% 100.0% 77.7%  
2004 2003 434 110,405 20,110 19,560 74,910 14,666 240,085 150,509 80
  % 0.2% 46.0% 8.4% 8.1% 31.2% 6.1% 100.0% 62.7%  
2005 2004 0 165,479 19,150 8,621 21,752 9,166 224,168 193,250 50
  % 0.0% 73.8% 8.5% 3.8% 9.7% 4.1% 100.0% 86.2%  
2006 2005 20 80,085 724 4,284 16,358 1,751 103,222 85,113 30
  % 0.0% 77.6% 0.7% 4.2% 15.8% 1.7% 100.0% 82.5%  


10C. NEW FORM Part A: Inclusion Enrollment Report (Total of All FOREIGN Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity Formats)
Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race
  Total of All Subjects by Race Total of All Subjects by Ethnicity
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White More Than One Race Unknown
or Not
Reported
*Total of All
Subjects by Racial Categories
(New Form)
Not Hispanic **Hispanic or
Latino
Unknown/
Not
Reported
*Total of All
Subjects by
Ethnic
Category
2002 2001 3,271 180,022 68,071 14,013 19,970 741 3,153 289,241 278,618 6,064 4,559 289,241
  % 1.1% 62.2% 23.5% 4.8% 6.9% 0.3% 1.1% 100.0% 96.3% 2.1% 1.6% 100.0%
2003 2002 2,018 1,842,941 62,572 14,501 253,745 5,324 7,018 2,188,119 2,158,933 9,623 19,563 2,188,119
  % 0.1% 84.2% 2.9% 0.7% 11.6% 0.2% 0.3% 100.0% 98.7% 0.4% 0.9% 100.0%
2004 2003 193 3,860,259 99,728 11,507 292,142 14,056 46,157 4,324,042 4,275,684 35,788 12,570 4,324,042
  % 0.0% 89.3% 2.3% 0.3% 6.8% 0.3% 1.1% 100.0% 98.9% 0.8% 0.3% 100.0%
2005 2004 1,171 2,390,404 125,305 10,293 187,697 18,857 94,999 2,828,726 2,683,871 52,801 92,054 2,828,726
  % 0.0% 84.5% 4.4% 0.4% 6.6% 0.7% 3.4% 100.0% 94.9% 1.9% 3.3% 100.0%
2006 2005 30,519 2,516,589 219,140 3,318 244,057 143,279 145,105 3,302,007 2,923,885 257,756 120,366 3,302,007
  % 0.9% 76.2% 6.6% 0.1% 7.4% 4.3% 4.4% 100.0% 88.5% 7.8% 3.6% 100.0%


10D. NEW FORM Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White (Hispanic) More Than One Race Unknown
or Not
Reported
**Total of
Hispanics or
Latinos by
Racial
Categories
FOREIGN Subtotal Using US Minority Categories (shaded): NEW FORM Parts A+B Number of Foreign
Protocols with Enrollment data
(New Form):
2002 2001 1,461 0 4 0 1,659 683 175 3,982 267,952 102
  % 36.7% 0.0% 0.1% 0.0% 41.7% 17.2% 4.4% 100.0% 92.6%  
2003 2002 1,644 3 1,222 0 632 4,528 1,594 9,623 1,929,582 213
  % 17.1% 0.0% 12.7% 0.0% 6.6% 47.1% 16.6% 100.0% 88.2%  
2004 2003 115 14 12,778 0 4,537 11,878 6,466 35,788 3,996,746 285
  % 0.3% 0.0% 35.7% 0.0% 12.7% 33.2% 18.1% 100.0% 92.4%  
2005 2004 682 6 164 0 26,161 14,664 11,124 52,801 2,583,315 321
  % 1.3% 0.0% 0.3% 0.0% 49.5% 27.8% 21.1% 100.0% 91.3%  
2006 2005 29,576 101 1,842 688 42,665 136,326 46,558 257,756 3,002,068 434
  % 11.5% 0.0% 0.7% 0.3% 16.6% 52.9% 18.1% 100.0% 90.9%  

* These totals must agree
** These totals must agree




11A. Part A. Phase III FIVE YEAR SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN PROTOCOLS (Old + New Forms)
FY Reported FY Funded Females Males Unknown
Total
Foreign Subjects
(Old + New Forms)
Subtotal: Foreign
Subjects Enrolled by
US Minority
Categories
Number of Foreign
Protocols with
Enrollment data
(Old + New Forms):
2002 2001 14,359 15,911 41 30,311 18,308 172
  % 47.4% 52.5% 0.1% 100.0% 60.4%  
2003 2002 28,037 21,237 136 49,410 23,927 209
  % 56.7% 43.0% 0.3% 100.0% 48.4%  
2004 2003 24,020 25,023 83 49,126 37,126 24
  % 48.9% 50.9% 0.2% 100.0% 75.6%  
2005 2004 29,388 23,163 2,547 55,098 44,281 30
  % 53.3% 42.0% 4.6% 100.0% 80.4%  
2006 2005 55,599 42,354 1,180 99,133 84,412 60
  % 56.1% 42.7% 1.2% 100.0% 85.2%  


Table 11A Comments:
  1. The percent females varied from 47.4% to 56.7% in Phase III foreign protocols from 2002-2006; the percent males varied from 42.0% to 52.5%.
  2. The percent foreign subjects enrolled by U.S. Minority Categories in Phase III foreign protocols increased from 60.4% to 85.2% from 2002 to 2006.
  3. Total Phase III foreign enrollment increased from 30,311 to 99,133 during these 5 years.
  4. The number of Phase III foreign protocols dropped from 209 in 2003 to 60 in 2006.


NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data.

NOTE 2: Data from Tables 11B, 11C and 11D are combined to provide the summary data in Table A.

11B.OLD FORM: Total of All FOREIGN Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity format
FY Reported FY Funded American
Indian/
Alaska
Native
Asian/ Pacific
Islander
Black or
African
American
Hispanic, Not
White
White Unknown
/Other
Total
Foreign
Enrollment
(Old Form)
Foreign Subtotal
Using US Minority
Categories (shaded):
OLD FORM
Number of Foreign
Protocols with
Enrollment data
(Old Form):
2002 2001 59 12,269 2,807 1,724 9,579 1,558 27,996 16,859 166
  % 0.2% 43.8% 10.0% 6.2% 34.2% 5.6% 100.0% 60.2%  
2003 2002 77 12,428 280 3,499 15,054 8,077 39,415 16,284 188
  % 0.2% 31.5% 0.7% 8.9% 38.2% 20.5% 100.0% 41.3%  
2004 2003 1 12,068 52 1,007 3,093 7,603 23,824 13,128 10
  % 0.0% 50.7% 0.2% 4.2% 13.0% 31.9% 100.0% 55.1%  
2005 2004 0 12,252 1 1,183 2,257 14 15,707 13,436 5
  % 0.0% 78.0% 0.0% 7.5% 14.4% 0.1% 100.0% 85.5%  
2006 2005 16 12,295 30 12 4,533 675 17,561 12,353 8
  % 0.1% 70.0% 0.2% 0.1% 25.8% 3.8% 100.0% 70.3%  


11C. NEW FORM Part A: Inclusion Enrollment Report (Total of All FOREIGN Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity Formats)
Part A: Total Enrollment Report: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race
  Total of All Subjects by Race Total of All Subjects by Ethnicity
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White More Than One Race Unknown
or Not
Reported
*Total of All
Subjects by Racial Categories
(New Form)
Not Hispanic **Hispanic or
Latino
Unknown/
Not
Reported
*Total of All
Subjects by
Ethnic
Category
2002 2001 0 1 1,448 0 113 0 753 2,315 1,562 0 753 2,315
  % 0.0% 0.0% 62.5% 0.0% 4.9% 0.0% 32.5% 100.0% 67.5% 0.0% 32.5% 100.0%
2003 2002 7 23 7,610 0 1,095 0 1,260 9,995 8,720 3 1,272 9,995
  % 0.1% 0.2% 76.1% 0.0% 11.0% 0.0% 12.6% 100.0% 87.2% 0.0% 12.7% 100.0%
2004 2003 0 12 21,414 0 553 2,570 753 25,302 21,972 2,572 758 25,302
  % 0.0% 0.0% 84.6% 0.0% 2.2% 10.2% 3.0% 100.0% 86.8% 10.2% 3.0% 100.0%
2005 2004 389 4,272 25,948 0 7,576 0 1,206 39,391 38,122 624 645 39,391
  % 1.0% 10.8% 65.9% 0.0% 19.2% 0.0% 3.1% 100.0% 96.8% 1.6% 1.6% 100.0%
2006 2005 1,906 27,048 27,513 5 8,093 169 26,838 91,572 60,670 17,484 3,418 81,572
  % 2.1% 29.5% 30.0% 0.0% 8.8% 0.2% 29.3% 100.0% 74.4% 21.4% 4.2% 100.0%




11D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date
FY Reported FY Funded American
Indian/
Alaska
Native
Asian Black or
African
American
Native
Hawaiian or
Pacific Islander
White (Hispanic) More Than One Race Unknown
or Not
Reported
**Total of
Hispanics or
Latinos by
Racial
Categories
FOREIGN Subtotal Using US Minority Categories (shaded):NEW FORM Parts A+B Number of
oreign
Protocols with Enrollment data (New Form):
2002 2001 0 0 0 0 0 0 0 0 1,449 6
  % 0.0% 0.0% 0.0% 0.0% 0.00% 0.0% 0.0% 0.0% 62.6%  
2003 2002 0 0 0 0 2 0 1 3 7,643 21
  % 0.0% 0.0% 0.0% 0.0% 66.7% 0.0% 33.3% 100.0% 76.5%  
2004 2003 0 0 0 0 2 2,570 0 2,572 23,998 14
  % 0.0% 0.0% 0.0% 0.0% 0.1% 99.9% 0.0% 100.0% 94.8%  
2005 2004 388 0 0 0 4 0 232 624 30,845 25
  % 62.2% 0.0% 0.0% 0.0% 0.6% 0.00% 37.2% 100.00% 78.3%  
2006 2005 1,849 3 213 0 1,328 1 14,090 17,484 72,059 52
  % 10.6% 0.0% 1.2% 0.0% 7.6% 0.00% 80.6% 100.0% 78.7%  

* These totals must agree
** These totals must agree


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