The NIH Clinical Trial Integrity Act requires the National Institutes of Health to mandate that clinical trial sponsors develop clear diversity goals reflecting the racial, ethnic, age, and sex composition of patient populations with the disease being studied or the general U.S. population. Sponsors must submit detailed recruitment and retention plans, implement less burdensome follow-up options like telemedicine or home visits, and provide annual data on participant demographics disaggregated by race, ethnicity, age, and sex. The bill also requires the NIH to conduct a study within two years on eliminating cost barriers to participation, authorize $10 million annually from fiscal years 2027 through 2030 for a public awareness campaign promoting diverse clinical trial participation, and direct the Government Accountability Office to examine federal efforts to address barriers to trial participation. Clinical trials already underway when the bill is enacted are exempt from these requirements.
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