NIH Clinical Trial Diversity Act of 2023

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.