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The FDA has just published new draft guidance on their Diversity Action Plans Required for Certain Clinical Studies. FDA Commissioner, Robert M. Califf, M.D., stated “Participants in clinical trials should be representative of the patients who will use the medical products”. So what does this mean for trials? 🎯 The action plan is designed to "increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product."  This will further improve the data, safety and efficacy of products for patients. ✅ Diversity Action Plans must specify the sponsor’s rationale and goals for clinical study enrollment (separated by the age group, ethnicity, sex and race of clinically relevant study populations) ✅ The plans must also describe how the sponsor intends to meet and expand on those goals. ✅ The plans apply to phase 3 studies or, as appropriate, other pivotal clinical studies of a drug or biological product and devices, including where the primary basis for the FDA’s evaluation is the safety and effectiveness and benefit-risk. ✅ The Diversity Action Plan requirment applies to clinical studies where enrollment starts 180 days the FDA publishes the final guidance The plan also has faced some criticism for falling short in some areas. For example: ⚡ There aren't clear consequences for sponsors who fail to meet their DEI action plan goals ⚡ A risk of budget and resource allocation issues in adding the new requirements to trial plans and how it might impact the effectiveness of the plans and solutions ⚡ The extent to which it applies beyond phase 3 drug and device trials is still foggy for sponsors. How can we support? 💡 Reach: Our system offers global reach to over 90,000 diverse communities across 157 countries and 2,700 indications. 💡 Planning: We can support with administrative automation of preparing your plans and actionable milestones. 💡 Partners: We can connect you to a number of our fantastic partners who engage and collaborate with underrepresented groups on the ground globally. The link to the FDA's draft Diversity Action Plan guidance is in the comments.

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