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S4440119th CongressWALLET

Clinical Trial Modernization Act

Sponsored By: Senator Scott, Tim [R-SC]

Introduced

Summary

Modernize clinical trials and reduce participation barriers for underrepresented populations. This bill would fund community outreach and training, let sponsors cover participant expenses and provide needed digital health tools, and create legal and tax protections to boost diverse enrollment.

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  • Families and participants: It would allow sponsors to remunerate participants for trial expenses like travel, transportation, and meals and to provide digital health technologies when necessary. Payments must be available to all study participants and aim to include people from varied demographic, socioeconomic, and geographic groups, including rural communities.
  • Community clinical sites and investigators: The bill would authorize grants and contracts to community health centers, academic health centers, rural sites, and other facilities for education, recruitment, multilingual materials, and training to increase the number of underrepresented health care personnel who serve as investigators.
  • Sponsors and manufacturers: It would create limits on civil monetary and false claims liability for sponsor payment of patient cost-sharing when eight conditions are met. It would also add a tax rule that excludes up to $2,000 of participant remuneration from gross income.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 2 benefits, 0 costs, 1 mixed.

Exclude some trial payments from tax

If enacted, you would be able to exclude up to $2,000 per taxable year of payments you receive for taking part in an approved clinical trial from your taxable income. The exclusion would apply only to payments from approved clinical trials and would start for taxable years beginning after the law takes effect. The exclusion amount would be limited to the actual payments you received that year, up to $2,000.

More help paying trial costs

If enacted, the bill would let sponsors and others give payments to cover trial-related expenses like travel, transportation, and meals for all study participants, and allow free provision of necessary digital health tools to participants. It would add Anti‑Kickback exceptions for those expense payments and for providing digital tools for participation, effective for remuneration on or after enactment. The bill would also create a safe harbor so drug and device makers could pay a participant's patient cost-sharing when a trial meets eight safeguards. Those safeguards include following federal coverage rules, making payments available throughout the trial, not exceeding a participant's actual cost-sharing, stopping payments if a participant leaves the trial, a participant agreement not to accept other financial help for the same cost-sharing, IRB or similar oversight, limits on advertising the subsidy, and a cap on total enrollment.

Grants to boost trial outreach

If enacted, the HHS Secretary would be able to award grants and enter contracts to fund community education, outreach, recruitment, and training for drug and device clinical trials that focus on conditions affecting underrepresented groups. Grants could pay for work with community health centers, training local investigators, partnerships with community groups and unions, and multilingual materials and outreach in tribal and other underserved areas. The bill would use NIH and FDA definitions to decide who counts as an underrepresented population. Congress would have to appropriate money; funds are authorized as necessary for fiscal years 2027 and 2028.

Sponsors & CoSponsors

Sponsor

Scott, Tim [R-SC]

SC • R

Cosponsors

  • Sen. Warner, Mark R. [D-VA]

    VA • D

    Sponsored 4/29/2026

Roll Call Votes

No roll call votes available for this bill.

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