On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials. Clinical trials that lack a diverse participant population have long been understood to worsen health disparities, as marginalized groups have been effectively denied the ability to participate in research that might improve their health. This has led those in the research and research ethics communities to call on stakeholders to take action to improve the representation of groups who have typically lacked it, including Black Americans, Indigenous and Native Americans, and Latinx Americans, among others.

The FDA guidance, Diversity Plans To Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials, is aimed at study sponsors and recommends mechanisms for enrolling diverse populations in clinical trials. The recommendations primarily revolve around a “Race and Ethnicity Plan,” which is designed “to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States” and which study sponsors can submit to the FDA as part of a new drug application. The guidance discusses what the plan should include, when to submit it, and other details you can read more about within the document itself.

Because the guidance is a draft, its content is open for public discussion and comment. Earlier this week, PRIM&R submitted comments to the FDA explaining how the guidance, while welcome, might be improved. Here’s what we focused on:

• The guidance should acknowledge the socially constructed nature of race and ethnicity. These descriptors are only scientifically relevant as proxies for a whole host of other measures that are more predictive of health outcomes, like geography, socioeconomic status, and healthcare access. The guidance does acknowledge that race and ethnicity are social constructs, but does so in a cursory way. We believe it should be front and center.

  We also believe that, rather than using the racial categories put forth by the Office of Management and Budget back in 1997, study sponsors would get more useful and scientifically relevant demographic information by allowing participants to self-identify their racial and ethnic descriptors.

• The FDA should make it clear that diversifying trials is a matter of justice, not just scientific imperative. Often, when the research community describes why it’s important for clinical trials to be racially and ethnically diverse, it is said that this issue matters because diversity increases the scientific validity of the findings. This is true—drugs that are studied in a diverse population are more likely to work in the diverse population that is our society. But, crucially, historically underrepresented populations deserve representation in trials because they deserve better access to the benefits of research—potentially lifesaving drugs and other interventions that can reduce health disparities.
• We also believe that the FDA can do more to help reduce the burdens of trial participation. Participating in a trial can be time-consuming, expensive, and otherwise burdensome for participants. This is especially so for historically underrepresented groups, who are more likely to lack the time, money, childcare options, health insurance, and other means, which make the burden of participation even greater. The FDA has the ability to encourage sponsors to make it easier for people to participate in trials, and we think the agency should do so more vigorously in this guidance document.
• The National Academies of Science, Engineering, and Medicine recently released a report called “Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups.” The report has a number of recommendations we agree the FDA should incorporate in its operations and requirements for sponsors, including: increased resources for data collection and tracking of enrolled participants, earlier and more detailed recruitment plans, guidance for local IRBs for paying participants, and more.

These changes would help improve this guidance document, which is a positive, if insufficient step in the right direction. Download and read our full comments for more information—we encourage you to borrow from our language and ideas and submit your own comments to the FDA. We’ve outlined how and why you should submit comments on our public policy webpage.  Comments are due June 13, 2022.