The COVID-19 pandemic has reminded all that track health, research and the impact of disease on minority and underserved or at risk populations. Racial and ethnic minorities such as African Americans and Hispanics, for example are disproportionately impacted by the coronavirus yet often don’t participate in vaccine trials nearly as much as the White population. Now to help turn this around, the U.S. Food and Drug Administration just made available its final guidance with the regulatory authority’s recommendations for designing and executing clinical trials of drugs and biologics with an emphasis on diverse participation. Issued on November 9, 2020 and titled “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs,” this is the culmination of drafts with comments that are part of a bid to broaden eligibility criteria in clinical trials. By embracing inclusive trial design and practices, as well as methodological approaches, the FDA seeks to contribute to the ongoing modernization and advancement of drug, diagnostic and device commercialization in the United States.
Recently, Stephen M. Hahn, MD stated recently, ‘The guidance aims to provide recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials.’ The FDA continues its mission to contribute to the goal of ensuring that clinical trials better reflect the population most likely to use the various drugs that are approved; a key goal involves the broadening of study eligibility criteria.
Call to Action: Read the actual guidance here.