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Washington Highlights

AAMC Submits Letter to FDA on Demographic Subgroup Data

November 22, 2013—AAMC Nov. 20 submitted a letter  to the Food and Drug Administration (FDA) in response to a report outlining the FDA’s use of tools to ensure submission of demographic information; the participation of women, the elderly, and racial and ethnic minorities in clinical trials; and on communication of this information to health care professionals and the general public.  The request for comment was published in the Aug. 22 Federal Register.

Given pervasive health and health care inequities across socio-demographic groups in the United States, in its letter the AAMC voices strong support for the inclusion of underrepresented groups such as women, minorities, and the elderly in clinical trials so that the safety and efficacy of drugs and devices can be generalized to all populations.

Acknowledging that no FDA regulation requires that research sponsors recruit demographic subgroups into clinical trials, the AAMC letter includes suggestions to increase recruitment of populations currently underrepresented in research.  The AAMC recommends the FDA synthesize the existing evidence base of effective recruitment strategies and make the summary easily available to sponsors to facilitate enrollment. 

Furthermore, the AAMC suggests that the FDA consider ways to incentivize the inclusion of underrepresented groups by, for example, developing a “fast track” mechanism for applications that (a) juxtapose data regarding subgroup disease prevalence with study sample demographics to assess alignment and (b) include a participant accrual plan that addresses subgroup recruitment goals.

The FDA report was required by the Food and Drug Administration Safety and Innovation Act of 2012 (P.L. 112-144), which directed the FDA to report on the inclusion and analysis of demographic subgroups in research it funds. In its report, the FDA noted that although tools and guidance exist and while some progress has been made in terms of recruitment, significant gaps persist in the participation of women, minorities, and the elderly in clinical trials, and many trials are underpowered to conduct meaningful subgroup analyses even when members of underrepresented populations have been enrolled. 

Contact:

Philip M. Alberti, PhD
Senior Director, Health Equity Research and Policy
Telephone: 202-828-0522
Email: palberti@aamc.org

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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org