On April 13, 2022, the U.S. Food and Drug Administration (FDA) presented new guidance for improving efforts to enroll more underrepresented racial and ethnic minorities in clinical trials. A crucial source of evidence for evaluating the safety and effectiveness of medical products, clinical trials should reflect the diversity of any population that might use the treatment being tested. However, even though racial and ethnic minorities often bear a disproportionate burden for certain diseases, minorities are often underrepresented in biomedical research. Addressing this knowledge gap is important because it has been shown that biological differences often exist in how individuals from different groups respond to certain therapies.
Improving the diversity of enrollment is no simple task. There are many potential barriers to participation among racial and ethnic groups ranging from mistrust of clinical research caused by historical abuses to inadequate recruitment and retention efforts. There could also be language, religion, and health literacy barriers that may need to be addressed by sponsors to increase participation in relevant clinical trials.
To this end, the FDA has put forward the Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials draft guidance. This draft encourages sponsors of medical products to develop a plan for improving race and ethnic diversity and to submit that plan to the FDA early on in clinical development. A framework is also provided in the new guidelines to help sponsors build their race and ethnic diversity plan.
As the population of the US becomes increasingly diverse, the importance of representation of minorities in clinical trials also increases. The FDA hopes that by increasing enrollment of diverse populations in the drug and medical treatment development process, a greater understanding of public health can be built and better treatments can be produced.