Collaboration Details

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Title of Collaborative Activity:

NIH-FDA Interagency Clinical Outcome Assessments (ICOA) Working Group

Description of Collaborative Activity:

The Interagency Clinical Outcome Assessments Working Group (ICOA WG) works to foster the development, evaluation, and qualification of Clinical Outcomes Assessments (COAs) for use in both medical product development and clinical research. Leveraging the unique strengths, knowledge, and resources at both the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the objectives of the ICOA WG are: (1) To increase communication between the relevant groups at FDA and the many separate efforts at NIH to advance measurement science by exchanging information about specific COA projects of common interest, thereby improving the knowledge base for COA development; (2) To clarify and disseminate information about the regulatory processes for evaluation of medical product development tools; (3) To foster appropriate interagency scientific efforts to generate evidence toward the development and potential qualification of novel COAs; and (4) To leverage public and private efforts toward consensus and standards development in this area. The ICOA WG is composed of representatives and selected senior staff of each agency

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:


NIH Participating Institutes/Centers/Office of the Director:


HHS Agency Collaborators on this Activity: