Bill · H.R. 3521· House(119-HR-3521)
Clinical Trial Modernization Act
- Introduced
- 5/20/2025
- Last activity
- 5/20/2025 — Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Sponsored by
- Raul Ruiz
- Cosponsors
- - 19 - 11
- Introduced
- In Committee
What this bill would do
The Clinical Trial Modernization Act aims to modernize clinical trials and remove barriers that prevent people from participating in them. The bill authorizes grants for community education, outreach, and recruitment to help underrepresented populations join clinical trials. It protects trial sponsors from certain legal penalties under the Anti-Kickback Statute and Civil Monetary Penalties Law when they cover trial expenses like travel, meals, or digital health technologies for participants. Additionally, the bill allows drug and device manufacturers to pay patient cost-sharing obligations under specific rules to reduce financial barriers. Finally, the legislation excludes up to $2,000 of trial remuneration from a participant's gross income for tax purposes.
Yes· 3 of 13
Does this make health care easier to get in general?+7
The bill reduces financial barriers to clinical trial participation through expense reimbursement and cost-sharing assistance.
Would Native Americans be better off under this?+6
The bill explicitly prioritizes outreach to tribal areas.
Does this narrow racial gaps in how people are treated?+6
The bill specifically aims to increase participation among underrepresented and diverse populations.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Grants for Community Outreach: Section 3 allows the Secretary to issue grants and contracts to support community education, outreach, and recruitment for clinical trials focusing on diseases that disproportionately impact underrepresented populations. This could help everyday folks in rural areas and tribal communities learn about and access medical trials.
-
Help with Trial Expenses: Section 4 amends the Social Security Act so that clinical trial sponsors can provide study participants with money for travel, transportation, and meals without violating the law. This ensures that financial hardships do not stop everyday people from participating in trials.
-
Free Digital Health Technologies: Section 4 also allows sponsors to freely provide digital health technologies to individuals if the technology is necessary and intended to facilitate the participation of underrepresented patient populations in clinical trials.
-
Help with Cost-Sharing: Section 5 protects drug and device manufacturers from certain legal penalties when they pay patient cost-sharing obligations for clinical trials, provided specific safety and eligibility requirements are met. This removes a potential financial barrier and helps lower the risk of patients dropping out of trials due to costs.
-
Tax Relief on Trial Payments: Section 6 excludes up to $2,000 of payments received from participating in an approved clinical trial from an individual's gross income for any taxable year. This means everyday people will not be taxed on the money they receive for participating in these trials up to that amount.
Potential Negative Impacts for People
- Restrictions on Financial Assistance: Section 5 requires that a participating patient receiving cost-sharing assistance must agree not to accept other financial assistance to cover those same cost-sharing obligations. This limits patients from combining different forms of financial help to pay for their trial costs.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Native Americans+6Good For African Americans+5Good For Asian Americans+5Good For Hispanic Americans+5Good For Low Income Households+5Good For Rural Residents+5Good For Middle Class Households+2
- Healthcare
- Improves Healthcare Access+7Increases Research Funding+5
- Social Issues And Justice
- Improves Racial Equity+6
- Education And Technology
- Increases Scientific Research Funding+5
- Environment Energy And Infrastructure
- Improves Rural Development+3
- Economy And Finance
- Reduces Middle Class Taxes+2
- 10/6/2026
- 6 Cosponsors added.
- 9/28/2026
- 3 Cosponsors added.
- 9/24/2026
- 9 Cosponsors added.
- 9/15/2026
- 4 Cosponsors added.
- 8/31/2026
- 1 Cosponsor added.
- 8/20/2026
- 2 Cosponsors added.
- 9/2/2025
- 1 Cosponsor added.
- 7/10/2025
- 1 Cosponsor added.
- 6/11/2025
- 1 Cosponsor added.
- 6/4/2025
- 1 Cosponsor added.
- 5/20/2025
- Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 1 Cosponsor added.
- Introduced in House
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Jake AuchinclossDemocrat · Massachusetts
Yassamin AnsariDemocrat · Arizona
Jack BergmanRepublican · Michigan
Janelle BynumDemocrat · Oregon
Emanuel CleaverDemocrat · Missouri
Henry CuellarDemocrat · Texas
Steve CohenDemocrat · Tennessee
Gilbert CisnerosDemocrat · California
Juan CiscomaniRepublican · Arizona
Debbie DingellDemocrat · Michigan
Jake EllzeyRepublican · Texas
Brian FitzpatrickRepublican · Pennsylvania
Maggie GoodlanderDemocrat · New Hampshire
Ashley HinsonRepublican · Iowa
Henry JohnsonDemocrat · Georgia
William KeatingDemocrat · Massachusetts
Thomas KeanRepublican · New Jersey
Zoe LofgrenDemocrat · California
Stephen LynchDemocrat · Massachusetts
Michael LawlerRepublican · New York
Greg LandsmanDemocrat · Ohio
Seth MoultonDemocrat · Massachusetts
Max MillerRepublican · Ohio
Eleanor NortonDemocrat · District of Columbia
August PflugerRepublican · Texas
Mark PocanDemocrat · Wisconsin
Terri SewellDemocrat · Alabama
Lloyd SmuckerRepublican · Pennsylvania
Darren SotoDemocrat · Florida
Randy WeberRepublican · Texas