Clinical Trial Modernization Act introduced to reform medical research protocols
May 20, 2025
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Where This Stands
Currently in_committee. The next step in the legislative lifecycle is Floor Vote.
Version history
Only one version on file - nothing to compare yet. As later stages (committee substitute, engrossed, enrolled) are captured, the redline appears here.
View official text →The Frame
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.
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.
Current stage: in_committee.
Floor Vote.
Summary
Key Facts
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Frequently Asked Questions
What is the Clinical Trial Modernization Act?
What is the current status of the bill?
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
Lobbying Activity
(C) MANAGEMENT INC.
on behalf of Association of Community Cancer Centers
2021
“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. ”
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Analysis Score
0–100- Significance40How much this matters to a regular citizen
- Controversy10Intensity of disagreement among stakeholders
- Entertainment5Compellingness for a non-policy-wonk reader
- Buzz15Current news / social attention level
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