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FDA Issues Draft Guidance on Diversity in Clinical Trial Populations


The guidance is aimed at helping sponsors recruit test populations that accurately represent real world populations.



In recent years, the pharmaceutical industry has become increasingly aware of the issue of a lack of diversity in clinical trials. In the past, this has resulted in trials being conducted on participants that either don’t match the real world population of potential patients or is too limited to provide a complete picture for potential side effects. While the industry has been taking steps to correct this, FDA is now getting involved.

The agency issued draft guidance directing companies running clinical trials to submit diversity action plans ahead of certain studies.1 These plans are designed to ensure that the studies are using a patient population that accurately represents real world populations and include under-represented groups.

The guidance, named “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” provides details on how these plans should be formatted and what content they should include. This include the sponsor’s goals for the study’s enrollment, what are the relevant study populations, and the methods that the sponsor intends to use to meet those goals.

In a press release, FDA Commissioner Robert M. Califf, M.D., said, “Participants in clinical trials should be representative of the patients who will use the medical products. The agency's draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved."

In April of this year, FDA announced that it had amended a regulation to make it explicit that in vitro diagnostic products are devices, in a move designed to help ensure the safety and effectiveness of laboratory developed tests (LDTs).2

In a press release issued at the time, Califf said, “LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person's risk of cancer, or aid in diagnosing heart disease and Alzheimer's. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work. The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust."

In the same press release, FDA’s director at the Center for Devices and Radiological Health Jeff Shuren, M.D., J.D., said, “Today's action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon. Through targeted enforcement discretion policies for certain categories of tests manufactured by a laboratory, we expect patients and health care professionals will continue to have access to the tests they need while having greater confidence that the tests they rely on are accurate."


  1. FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies. FDA. June 26, 2024. https://www.prnewswire.com/news-releases/fda-guidance-provides-new-details-on-diversity-action-plans-required-for-certain-clinical-studies-302183322.html
  2. FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests. FDA. April 29, 2024. Accessed June 26, 2024. https://www.prnewswire.com/news-releases/fda-takes-action-aimed-at-helping-to-ensure-the-safety-and-effectiveness-of-laboratory-developed-tests-302130166.html
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