Clinical Trial Modernization Act

The Clinical Trial Modernization Act aims to broaden participation in clinical trials and ease access for populations that have been historically underrepresented. It does this through targeted grants for outreach and training, allowances for sponsor-funded participant cost-sharing and digital health technologies to facilitate inclusion, and a tax-related exemption for stipends paid to trial participants. The bill also creates stricter safeguards to ensure these arrangements do not run afoul of fraud or improper billing rules, while preserving existing liability protections. Overall, the bill seeks to reduce financial and logistical barriers to trial participation, particularly in rural, tribal, and multilingual communities, and to encourage a more diverse and representative pool of participants in trials for devices, drugs, vaccines, and related interventions. If enacted, it could influence how sponsors design trials, allocate resources for recruitment, and interact with participants, as well as how trial-related payments are treated for tax and compliance purposes.