Clinical Trial Modernization Act

The Clinical Trial Modernization Act aims to increase participation in clinical trials, especially by underrepresented populations, by providing grants, clarifying legal allowances for paying participant expenses and cost-sharing, and offering a tax exclusion for trial payments.

Sec. 2, Definition: The term "underrepresented population" has the meaning given by the National Institutes of Health in its Toolkit for Patient-Focused Therapy Development (as published April 1, 2024), plus any populations recognized by the Food and Drug Administration.

Sec. 3, Grants to encourage clinical trial enrollment by underrepresented populations: The Secretary may issue grants and contracts to support community education, outreach, and recruitment for clinical trials on devices and drugs (including vaccines) for diseases that disproportionately affect underrepresented populations. Activities may include working with community trial sites, training health care personnel (especially from underrepresented groups), engaging community stakeholders, and fostering partnerships with community organizations. Priority goes to entities that develop multilingual materials or conduct outreach in traditionally underrepresented communities, such as tribal areas. For fiscal years 2024 and 2025, such sums as necessary are authorized.

Sec. 4, Encouragement of clinical trial participation through payment of expenses and provision of digital health technologies: The Social Security Act is amended to allow remuneration (other than patient cost-sharing) for expenses like travel, transportation, and meals during a clinical trial, as long as it is available to all participants and facilitates inclusion of diverse populations and geographies, including rural communities. It also allows free provision of digital health technologies needed for participation and intended to facilitate inclusion of underrepresented populations. Conforming changes are made to the anti-kickback statute. These amendments apply to remuneration provided on or after enactment.

Sec. 5, Encouragement of clinical trial accessibility through support of cost-sharing: Payment of patient cost-sharing obligations by drug or device manufacturers for clinical trial participants is not a violation of the Civil Monetary Penalties Law, anti-kickback statute, or False Claims Act, provided eight conditions are met: the trial and coverage comply with applicable federal health care program rules; the arrangement is a reasonable means to facilitate enrollment of underrepresented subjects or reduce attrition; payments are available for the entire trial; payments are not contingent on future use or purchase of any product; payments do not exceed the patient's cost-sharing obligations; the patient agrees not to accept other financial assistance for cost-sharing; payments stop upon disenrollment or trial conclusion; and the arrangement includes protections against improper costs or utilization (no advertising, formal enrollment criteria and informed consent, written investigator agreement with oversight, and a cap on total enrollment).

Sec. 6, Exclusion from gross income for remuneration provided by sponsors of approved clinical trials to participants: The Internal Revenue Code is amended to exclude from gross income the value of any payment received by an individual from participation in an approved clinical trial, up to $2,000 per taxable year. This applies to taxable years beginning after enactment.