ARTICLE SUMMARY:
What to expect from oncoming FDA requirements for clinical study diversity action plans and practical considerations for designing and carrying out trials that are more representative of the population—experts from MCRA, an IQVIA business, discuss recent FDA draft guidance, protocol development, decentralized trials, and more in this edition of Consultants Corner.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
The need to take action to diversify clinical trials is moving from the realm of recommendation to that of legal requirement.
In the Food and Drug Omnibus Reform Act of 2022, Congress mandated that device and drug companies submit “diversity action plans” for clinical trials that support FDA authorizations. In 2024, the agency published a draft guidance toward implementing this requirement. Under the law, FDA is supposed to finalize a guidance by June (nine months after the draft guidance comment period closes), and the mandate for diversity action plans would then take effect six months later, in late December 2025. It’s not necessarily expected that the new Trump administration HHS/FDA leadership will hold to that timeline. Nonetheless, the prospect of more formalized FDA mandates underscores the need for device companies and clinical institutions to improve study enrollment and retention strategies to ensure better representation by underrepresented subgroups.
“Five years ago, looking at different clinical trial protocols, within different therapeutic areas, very rarely was diversity mentioned in the protocols,” said Kenneth Rayl, director of clinical affairs at consultancy MCRA, an IQVIA business. “That's unfortunate because ... different treatment options, different medical devices impact different populations differently,” he noted during a November 19 panel discussion moderated by Market Pathways at the MedTech Strategist Innovation Summit in San Diego.
