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NIH Clinical Trial Diversity Act of 2023
3/13/2024, 7:48 AM
Summary of Bill S 1701
The Act requires the NIH to develop and implement a plan to increase diversity in clinical trials, including strategies to recruit and retain participants from underrepresented groups. The bill also mandates the collection and reporting of data on the demographic characteristics of clinical trial participants, in order to track progress towards achieving greater diversity.
Additionally, the Act establishes a task force to provide recommendations on how to improve diversity in clinical trials, as well as funding for research on the barriers to participation faced by underrepresented populations. The goal of the legislation is to ensure that clinical research studies funded by the NIH are more inclusive and representative of the diverse population of the United States. Overall, the NIH Clinical Trial Diversity Act of 2023 aims to address disparities in healthcare outcomes by promoting greater diversity in clinical trials, ultimately leading to more effective and equitable treatments for all Americans.
Congressional Summary of S 1701
NIH Clinical Trial Diversity Act of 2023
This bill sets out requirements to increase the diversity of clinical trial participants. The bill also requires other activities to foster participation in clinical trials.
As a condition of funding from the National Institutes of Health (NIH) for a clinical trial investigating a drug or device, a sponsor's application must include certain information related to diversity in its trial, such as goals for recruiting and retaining trial participants and plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements. A sponsor must also annually share demographic data of clinical trial participants with the NIH.
Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials.
