HR3521119th CongressWALLET

Clinical Trial Modernization Act

Sponsored By: Representative Rep. Ruiz, Raul [D-CA-25]

Introduced

Summary

expand access and participation of underrepresented populations in clinical trials and modernize how sponsors support participants with payments and digital tools. This bill would target outreach, payments, and tax treatment to make trials more inclusive.

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Bill Overview

Analyzed Economic Effects

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

Tax break for clinical trial payments

If enacted, you could exclude up to $2,000 each year from your taxable income for payments from an approved clinical trial. This would apply to tax years that start after enactment. The payment must come from an approved clinical trial under federal rules.

More sponsor help for trial costs

If enacted, trial sponsors could pay your copays and coinsurance for trial care when strict safeguards are met. They would also be allowed to cover travel, rides, and meals, and to give needed digital tools, for all participants. The help must follow coverage rules, be available for the full trial, not be tied to buying products, stop when you leave, and you cannot double-dip; IRB oversight and enrollment caps would apply. These allowances would apply to support given on or after enactment and would not limit other existing legal protections.

Grants to reach underrepresented trial patients

The government would fund grants and contracts to teach, recruit, and support clinical trial participation in underrepresented communities. Priority would go to groups that use multilingual materials and work in places like tribal areas and rural sites. Money is authorized for 2025 and 2026 as such sums as needed. The bill would use NIH and FDA definitions to decide who counts as underrepresented.

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Sponsors & CoSponsors

Sponsor

Rep. Ruiz, Raul [D-CA-25]

CA • D

Cosponsors

  • Pfluger

    TX • R

    Sponsored 5/20/2025

  • Ciscomani

    AZ • R

    Sponsored 6/4/2025

  • Rep. Cohen, Steve [D-TN-9]

    TN • D

    Sponsored 6/11/2025

  • Rep. Soto, Darren [D-FL-9]

    FL • D

    Sponsored 7/10/2025

  • Rep. Auchincloss, Jake [D-MA-4]

    MA • D

    Sponsored 9/2/2025

Roll Call Votes

No roll call votes available for this bill.

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