NIH Clinical Trial Diversity Act of 2023

This bill requires sponsors of NIH-funded or NIH-approved clinical trials (for drugs, devices, biological products, or behavioral interventions) to set specific, measurable goals for recruiting participants reflecting race, ethnicity, age, and sex - either based on disease prevalence or the U.S. population. Key mechanisms include mandating detailed plans for achieving these goals, annual reporting of demographic data (without personally identifiable information), and strategies to reduce participation barriers like virtual visits or flexible scheduling. It also requires training for researchers on diversity and health inequities, and establishes a remediation process if goals aren’t met. The law aims to improve representation in clinical trials to ensure medical research better serves all patient groups.