The NIH Clinical Trial Integrity Act directs the National Institutes of Health to require sponsors of federally approved clinical trials to establish clear, measurable goals for recruiting and retaining participants that reflect the race, ethnicity, age, and sex of patients with the disease being studied or the general U.S. population. Sponsors must submit detailed plans showing how they will achieve diverse enrollment, implement less burdensome follow-up options, and provide diversity training to researchers, with annual reporting of participant demographics disaggregated by demographic categories. If a trial fails to meet enrollment goals, the sponsor must develop and implement a strategic plan to increase participation among underrepresented groups in consultation with community organizations. The bill exempts ongoing trials and directs a Government Accountability Office study on federal efforts to address barriers to clinical trial participation.
