Clinical Trial Modernization Act

Summary#

The Clinical Trial Modernization Act aims to increase participation in clinical trials, especially by groups that are underrepresented. It defines "underrepresented population" by referring to the National Institutes of Health and the Food and Drug Administration. Key provisions include:

  • Grants and contracts to support community education, outreach, recruitment, and investigator training at community trial sites, with priority for multilingual materials and outreach to traditionally underrepresented communities (for example, tribal areas). The bill authorizes appropriations for fiscal years 2025 and 2026 for these grants.
  • Changes to federal fraud and abuse rules so that reasonable payments to study participants for trial expenses (like travel, transportation, and meals) and the free provision of digital health technologies needed for participation are treated as allowable in specific circumstances. These changes amend parts of the Social Security Act and apply to remuneration provided on or after enactment.
  • A safe harbor that allows drug or device sponsors to pay patient cost-sharing obligations for trial participants without triggering certain federal penalties, if a list of conditions is met (for example, coverage consistent with federal program rules, payments available for the whole trial, payments not tied to future purchases, caps on enrollment, informed consent and oversight requirements, and limits on advertising the subsidies).
  • A tax rule that excludes from gross income up to $2,000 per year for payments an individual receives from participating in an approved clinical trial, for taxable years beginning after enactment.
  • A rule of construction saying the bill does not limit other existing protections from liability that may apply to practices encouraging clinical trial participation.

What it means for you#

If enacted, the bill would create grants for local outreach and training to boost trial enrollment among underrepresented groups. It would let study organizers provide payments for out-of-pocket trial expenses and provide necessary digital health tools without those payments automatically being treated as illegal remuneration, if the bill’s conditions are met. Sponsors could also pay patients’ cost-sharing for trial care under strict rules. People who get payments for trial participation could exclude up to $2,000 of that income on their federal tax returns for tax years after the law starts.

Expenses#

  • The bill authorizes funding "such sums as may be necessary" for the grants in fiscal years 2025 and 2026.
  • No publicly available information on total federal costs, budget offsets, or projected revenue effects from the tax exclusion beyond what is written above.

Proponents' View#

The bill states its purpose is to modernize clinical trials and remove barriers to participation, and it includes steps intended to increase enrollment and access for underrepresented populations (grants, allowable participant payments and digital tools, and sponsor cost-sharing rules).

Opponents' View#

No publicly available information.