{"id":70799,"date":"2024-01-09T17:35:21","date_gmt":"2024-01-09T17:35:21","guid":{"rendered":"https:\/\/www.imperialcrs.com\/blog\/?p=70799"},"modified":"2024-01-09T18:03:06","modified_gmt":"2024-01-09T18:03:06","slug":"pending-fda-clinical-trial-diversity-requirements","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/business-insights\/pending-fda-clinical-trial-diversity-requirements\/","title":{"rendered":"Pending FDA Clinical Trial Diversity Requirements"},"content":{"rendered":"

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.<\/p>\n

Right now, almost a half million studies are registered on ClinicalTrials.gov<\/a>, and about 65,000 are currently recruiting. We often say participants are the heroes of research, and sponsors apply great resources to recruit them.<\/p>\n

We all know the statistics regarding minority representation<\/a> in clinical trials. Too often, the patients who will ultimately use the drugs and devices under study are not adequately represented in trials. The following statistics show demographics for participation in clinical trials compared to the actual population of the U.S.<\/p>\n

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Overall, the inclusion of diverse race\/ethnic populations in clinical trials has improved over the years, but the numbers above show that minority study populations do not yet match their percentages of the U.S. population. If the drug or device is to be used worldwide<\/a>, there is even more disparity in representation.<\/p>\n

Sponsors and the FDA<\/a> have recognized the importance of including racial and ethnic minority groups, as well as other populations experiencing health disparities. Efforts seem to be progressing toward including these populations and may involve common strategies such as using advocacy groups to promote trial awareness and making recruitment materials more inclusive.<\/p>\n

FDA guidance documents address diversity, often stressing the importance of selecting sites located in areas where larger populations of diverse people reside and receive their health care.<\/p>\n

Around the corner: the U.S. will require a clinical trial diversity action plan<\/strong><\/h2>\n

Until recently, diversity goals have been addressed under a draft guidance<\/a> from the FDA. A government funding bill called the Consolidated Appropriations Act 2023 (H.R. 2617), signed into law by President Biden is bringing diversity to the next level.<\/p>\n

Inside the legislation is the Food and Drug Omnibus Reform Act of 2022, called FDORA, which specifies the goals of promoting diversity, decentralization, and the modernization of clinical trials. In the legislation, sponsors of some clinical trials will be required to submit a diversity action plan (DAP) to the Secretary of the Department of Health and Human Services. If you\u2019d like a look at the long legal document, check it out here<\/a>; for the diversity action plan, start with Subtitle F, which you will find deep down on page 1,402.<\/p>\n

What will sponsors be expected to provide in the DAP?<\/p>\n