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NIH-FDA Interagency Clinical Outcome Assessments Working Group

Charter: 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 FDA and the 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.
  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.

Representatives from the NCI include: Dr. Steven Clauser (DCCPS), Dr. Sandra Mitchell (DCCPS), Dr. Ann O'Mara (DCP) and Dr. Lori Minasian (DCP)

For more information, contact the Co Chairs:
Dr. Susana Serrate-Sztein; NIH NIAMS (szteins@mail.nih.gov) and Captain Laurie Burke, FDA CDER (Laurie.Burke@fda.hhs.gov)

Last Modified: 11 Apr 2014