# NIH Clinical Trial Diversity Act of 2023

This bill requires the National Institutes of Health (NIH)—the federal agency that funds medical research—to make sure that clinical trials (the studies that test new medicines and treatments on real people) include diverse participants. Right now, many clinical trials don't adequately represent different racial and ethnic groups, older adults, women, and people with disabilities. This bill aims to fix that problem by setting requirements and tracking progress.

Here's why this matters: when clinical trials don't include diverse groups, researchers may miss important information about how treatments work differently for different people. A medication that works well for one group might have different effects or side effects for another. By requiring more diverse participation, the bill helps ensure that new treatments are actually safe and effective for everyone who might use them, not just the groups that have traditionally been overrepresented in research. This is especially important because some diseases affect different populations differently, and some groups have historically been excluded from medical research.

The bill requires the NIH to establish standards for diversity in clinical trials and to collect data on who is actually participating in these studies. Researchers who receive NIH funding would need to follow these diversity requirements and report their progress. The agency would also need to identify barriers that prevent certain groups from participating—like lack of transportation, childcare, or trust in the medical system—and work to remove those obstacles. Over time, this should lead to medical treatments that are tested on and proven safe for a broader range of Americans, ultimately improving healthcare for everyone.

NIH Clinical Trial Diversity Act of 2023

Menendez, Robert

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.