FDA Working to Encourage Diversity and Equity in Clinical Trials

Stevens & Lee

Stevens & Lee

The FDA has recently made efforts to encourage more diversity and equity in clinical trials by releasing “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

While progress has been made with representation of white women in clinical trials, a report was released outlining the United States’ shortcomings in the representation of racial and ethnic minority population groups in clinical trials.

Clinical trials aim to improve the health of the country by finding ways to prevent, diagnose or treat diseases. However, if the answers that we find through clinical trials are only representative of a homogenous group, those answers will only benefit that one group.

A CDC study and other studies emphasize that racial and ethnic minority populations experience higher rates of poor health and disease in a range of health conditions. The lack of diversity in clinical trials and lack of answers for these groups only widens health disparities and inequities even further.

FDA Commissioner Robert M. Califf, M.D. explains, “The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health. Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

The FDA’s “Diversity Plans” serve as general guides for medical product sponsors. They suggest when Race and Ethnicity Diversity Plans should be implemented and what they may include. The FDA recommends that a Diversity Plan should be submitted to the investigational new drug application for clinical trials relating to drug products. For medical devices, a Diversity Plan should be submitted to the investigational device exemption application.

The FDA’s framework outlines general elements of a Plan, and for each element, there is a subsequent recommended scope:

1. Overview of the disease/condition

2. Scope of medical product development program

3. Goals for enrollment of underrepresented racial and ethnic participants

4. Specify plan of action to enroll and retain diverse participants

5. Status of meeting enrollment goals (as applicable)

The FDA’s diversity efforts in clinical trials are critical for efforts to ameliorate the health disparity of our nation’s minority populations. Clinical trials can never completely reach their potential unless they serve our diverse country rather than a homogenous group.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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