Medical products are safer and more effective for everyone when clinical research includes diverse populations.
Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race, and ethnicity) in applications for medical products — drugs, biologics, and devices, submitted to the agency for marketing approval:
1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.
It is important to test drugs and medical products in the people they are meant to help. The FDA works to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The links below provide information on different populations and their involvement in clinical trials for medical products.
The Office of Minority Health is leading groups made up of many FDA centers to develop actions to reduce health disparities.
- FDASIA Section 907 required the FDA to provide Congress with an action plan detailing “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers” and to indicate the center(s) tasked with each recommendation. Congress directed the Agency to issue the action plan one year following the Sec. 907 reports publication.
- More information on CERSI (Centers of Excellence in Regulatory Science and Innovation)
- Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
- Questions and Answers about section 907
- Drug Trials Snapshots: Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported new drugs' FDA approval. The Snapshots' information also highlights any differences in the benefits and side effects among sex, race, and age groups. Drug Trials Snapshots as part of an overall FDA effort to make demographic data more available and transparent.
More Information on Diversity in Clinical Trials
- Men During Their Reproductive Years
It gives men who were previously excluded because of potential reproductive harm access to clinical trials to treat life-threatening diseases. - Women
See how the FDA and the Office of Women’s Health are working for diversity in clinical trials. - Minority Health Resources
See how the FDA Office of Minority Health keeps you informed about; safe medication use, diabetes, food safety, product approvals, HIV/AIDS, and clinical trials. - Racial/Ethnic Groups
Reviews the participation of racial or ethnic groups in clinical trials (data from 1995 to 1999). - NIH Office of Equity, Diversity, and Inclusion
Sexual and Gender Minority - Older Adults
Information on why older adults should participate in clinical trials. - Children
A Consumer Update article from January 2010 on children and clinical trials.
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