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HR3521FEDERALin_committee

Clinical Trial Modernization Act introduced to reform medical research protocols

Original title: Clinical Trial Modernization Act

May 20, 2025

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Where This Stands

Introduced
Committee
Floor Vote
Passed
Signed

Currently in_committee. The next step in the legislative lifecycle is Floor Vote.

Last action
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.May 20, 2025

Version history

Only one version on file - nothing to compare yet. As later stages (committee substitute, engrossed, enrolled) are captured, the redline appears here.

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The Frame

What this does

This legislation could alter the requirements and timelines for medical research studies, directly impacting how pharmaceutical companies and research institutions conduct trials for new treatments.

Who is mentioned in the record

Potentially affected actors named in the source documents. Mention is not a position.

Pharmaceutical companies

These entities conduct clinical trials and would be subject to any new regulatory standards established by the act.

Medical research institutions

These organizations manage clinical trial sites and would be required to comply with updated research protocols.

What changed

Current stage: in_committee.

What's next

Floor Vote.

Summary

The Modernization Act, introduced on May 20, 2025, proposes updates to the regulatory framework governing clinical research. The bill has been referred to the House Committees on Energy and Commerce and Ways and Means for review.

Key Facts

You don't have to trust us. Each fact below is taken straight from the official document - click any one to see the exact passage, highlighted in the original.

Frequently Asked Questions

What is the Clinical Trial Modernization Act?
It is a piece of federal legislation introduced in the House of Representatives on May 20, 2025, aimed at updating regulations.
What is the current status of the bill?
The bill has been referred to the House Committee on Energy and Commerce and the Committee on Ways and Means for consideration.

Why It Matters

This legislation could alter the requirements and timelines for medical research studies, directly impacting how pharmaceutical companies and research institutions conduct trials for new treatments.

News Coverage

No news coverage found yet. Articles are indexed twice daily.

Lobbying Activity

(C) MANAGEMENT INC.

on behalf of Association of Community Cancer Centers

2021

GOVERNMENT ISSUESHEALTH ISSUES

THE TELEHEALTH MODERNIZATION ACT (H.R. 1332/ S.368) Organized a Virtual Capitol Hill Day for ACCC members (70+) on May 12th, 2021. Created one-pagers and talking points on importance of this legislation. ACCC views telehealth expansion as critical for cancer patient access to healthcare providers. THE SAFE STEP ACT (H.R.2163/S.464) Organized a Virtual Capitol Hill Day for ACCC members (70+) on May 12th, 2021. Created one-pagers and talking points on importance of this legislation. ACCC views step therapy in the use of cancer care delivery to be a hinderance to best practice and timely treatment/access of care for patients. THE ACCESS TO GENETIC COUNSELOR SERVICES ACT (H.R. 2144/S.1450) Organized a Virtual Capitol Hill Day for ACCC members (70+) on May 12th, 2021. Created one-pagers and talking points on importance of this legislation. ACCC views genetic counselors as integral members of the cancer care delivery team in oncology programs/practices in the US. THE RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT (H.R. 869/S.289) Organized a Virtual Capitol Hill Day for ACCC members (70+) on May 12th, 2021. Created one-pagers and talking points on importance of this legislation. ACCC understands the importance of research funding for the NIH and oncology investigators to promote clinical trials that impact improving cancer outcomes. THE MEDICARE MULTI-CANCER EARLY DETECTION SCREENING COVERAGE ACT OF 2021 (H.R. 1946) Organized a Virtual Capitol Hill Day for ACCC members (70+) on May 12th, 2021. Created one-pagers and talking points on importance of this legislation. ACCC advocates for the use and coverage of cancer screening modalities that will diagnose cancer at earlier stages therefore improving patient outcomes. MOST FAVORED NATION (Proposed by Trump Administration at end of 2020) ACCC entered into a lawsuit against HHS in December 2020 opposing the Most Favored Nation proposal tying drug reimbursements to international reference pricing. By lowering reimbursement to cancer programs and practices, patient access to care would be limited as supportive cancer care services limited due to lack of reimbursement to cover positions. ACCC was concerned over programs/practices closing if proposal were to move forward. ACCC met with one Senators office on this topic expressing concern in January 2021. RADIATION ONCOLOGY MODEL (Proposed by CMMI) ACCC met with 1 Senate office and 1 House office over concerns re: this alternative payment model. ACCC has concerns over mandatory nature of Radiation Oncology model testing reimbursement rates and potentially limiting access to care for patients who are recommended radiation for their cancer diagnosis, particularly in rural areas of the U.S.

Connected Entities

organizationCommittee on Energy and CommerceHouse committee assigned to review the bill.Map →
organizationCommittee on Ways and MeansHouse committee assigned to review the bill.Map →

Analysis Score

0–100
  • Significance40
    How much this matters to a regular citizen
  • Controversy10
    Intensity of disagreement among stakeholders
  • Entertainment5
    Compellingness for a non-policy-wonk reader
  • Buzz15
    Current news / social attention level

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