FDA's Push For Diversity: Addressing Data Challenges In Clinical Trials Through Updated Race And Ethnicity Guidance

By Lya Rebelo, Manager, Commercial Enablement

The US Food and Drug Administration (FDA) has introduced draft guidance to foster diversity in clinical trials. This updated version, which replaces the 2016 guidance, offers standardized suggestions for gathering and reporting race and ethnicity data in clinical trials for FDA-regulated medical products. The initiative is designed to ensure that clinical research is inclusive and representative of diverse populations.

Furthermore, the updated guidance broadens its reach to encompass non-interventional studies and interventional clinical trials. It encourages compliance with the 1998 final rule on the presentation of demographic data in new drug applications and the collection of race and ethnicity data in biologics license applications and medical device applications. The FDA is welcoming public feedback on the draft guidance until April 29, 2024. This step is crucial in ensuring that the benefits and risks of medical products are accurately assessed for all population groups, thus promoting health equity.