FDA Issues Draft Guidance on Diversity and Inclusion in Clinical Trials

Wednesday, August 10, 2022

Source: The National Law Review

By Lisa L. Smith and George Hajduczok

With its disproportionately greater impact on minority populations in the United States, the COVID-19 pandemic has illuminated longstanding health inequities in the United States, and increased attention on the importance of including racial and ethnic minorities in clinical trials for vaccines and other medications.  The U.S. Food and Drug Administration (FDA or “Agency”) has taken a leading role in promoting greater diversity and inclusion in clinical trials, most recently in its April 2022 draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for IndustryAvailability (“2022 Draft Guidance”).[1] 

Race and Ethnicity Matter in Drug Development

Race and ethnicity can serve as surrogates for biological differences in drug response. For instance, race-based differences in the metabolism and disposition of some drugs due to genetic variations have been identified.[2]  These differences can require alterations in drug dosing to achieve the desired result.  As an example, interpatient variability has been observed across ethnicities when optimizing maintenance dosing of the anticoagulant medication warfarin.[3]  This variability is believed to be due to genetic variations that affect the enzyme responsible for warfarin’s metabolism.  The potential for racial and ethnic contributions to drug action should be a consideration in the drug development process.

The makeup of clinical trial participants remains biased for the White population, even though the White (alone) population comprises just 60% of the population in the U.S.[4]  In February 2021, the FDA published a report reviewing the demographics of clinical trial participants involved in 53 drug approvals in 2020, and found that 75% of the 32,000 patients enrolled were White, whereas 8% were Black or African American, 6% were Asian, and 11% were Hispanic.[5]  The FDA’s report highlights the level of disproportion in the demographics of clinical trial participants as compared to the demographics of the U.S. population.  To the extent that the disproportional demographics of clinical trial participants diminish the confidence in those trials by underrepresented populations, the disproportionality also contributes to the health care disparities of underserved populations. 

The scientific community and U.S. Congress have been addressing the issue of racial and ethnic disparities in clinical trials for decades.  The National Institutes of Health (NIH) Revitalization Act of 1993 established guidelines for the inclusion of women and minorities in clinical research and required a valid analysis of whether the variables being studied affect women or members of minority groups differently than other trial participants.[6]  The 21st Century Cures Act, signed into law on December 13, 2016, also requires the NIH director to include women and minorities in NIH-funded clinical research in addition to requiring a valid analysis of the variables.[7]  As discussed below, in recent years, the FDA has endeavored to increase participation of underrepresented populations in clinical trials, most recently with its latest 2022 Draft Guidance.

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