National Institutes of Health Clinical Trials Grants

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National Institutes of Health Clinical Trials Grants
Type Program
Sponsor Organization National Institutes of Health
Top Organization Department of Health and Human Services
Creation Legislation Public Health Service Act of 1944 (Public Law 78-410), expanded by 21st Century Cures Act of 2016 (Public Law 114-255)
Website Website
Purpose NIH Clinical Trials Grants fund investigator-led trials on interventions like drugs and therapies to boost health, ensuring rigorous science nationwide.
Program Start 1945 (expanded in 2017 for clinical trials policy)
Initial Funding $5 million (initial clinical research funding)
Duration Ongoing
Historic No

The National Institutes of Health (NIH) Clinical Trials Grants, rooted in the Public Health Service Act of 1944 and expanded under the 21st Century Cures Act of 2016, are administered by the National Institutes of Health (NIH) within the Department of Health and Human Services through its institutes and centers (e.g., National Cancer Institute, National Heart, Lung, and Blood Institute) to provide competitive grants to researchers, allocating over $100 billion since inception to support approximately 10,000 clinical trials annually by 2025. Initially supported with $5 million for early clinical research, it has grown to distribute $10 billion in FY 2024 across 10,000 awards, funding trials for diseases like cancer, Alzheimer’s, and COVID-19 at academic and research institutions nationwide.[1] Despite its impact, challenges like funding competition, regulatory complexity, and participant recruitment persist (web ID: 6), but it remains a cornerstone of NIH’s clinical research efforts.

Official Site

Goals

  • Advance medical knowledge through rigorous clinical trials evaluating interventions like drugs, devices, and therapies.
  • Improve patient care and public health outcomes by supporting innovative and translational research.
  • Ensure scientific integrity, transparency, and adherence to ethical standards, including registration on ClinicalTrials.gov.[2]

Organization

The NIH Clinical Trials Grants program is managed by NIH, overseen by Director Monica M. Bertagnolli since 2023, with institutes and centers implementing grants under federal oversight. It operates via annual appropriations, guided by the Public Health Service Act, 21st Century Cures Act, and subsequent funding acts like Public Law 117-328 (2022).[3]

Partners

History

Authorized by the Public Health Service Act of 1944 (Public Law 78-410) and expanded by the 21st Century Cures Act of 2016 (Public Law 114-255), and launched with $5 million for early clinical research in 1945, the NIH Clinical Trials Grants program grew with annual appropriations, reaching $10 billion in FY 2024.[4] It expanded from funding 1,000 trials annually in 1946 to 10,000 by 2025, addressing health challenges with innovations like precision medicine trials (web ID: 6). By 2025, it has awarded over $100 billion, though GAO notes funding competition concerns (web ID: 6).

Funding

Initial funding of $5 million in 1945 (for early clinical research) supported the program’s launch, with over $100 billion appropriated by 2025 via annual HHS budgets—e.g., $10 billion in FY 2024.[5] Ongoing appropriations under the Public Health Service Act and 21st Century Cures Act sustain its operations, with no fixed end as it addresses ongoing clinical research needs.

Implementation

NIH Clinical Trials Grants distribute competitive grants annually, requiring investigators to submit trial protocols meeting NIH standards, tracked via NIH’s eRA Commons and ClinicalTrials.gov registration.[6] It progresses through partnerships with research institutions—e.g., 10,000 trials yearly—and program expansions, adapting to health needs with no set end, though participant recruitment remains a challenge (web ID: 6).

Related

External links

Social media

References

  1. ↑ "NIH Clinical Trials Policy". National Institutes of Health. https://grants.nih.gov/policy/clinical-trials.htm. 
  2. ↑ "NIH Clinical Research Trials and You". National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you. 
  3. ↑ "About NIH Leadership". National Institutes of Health. https://www.nih.gov/about-nih/who-we-are/leadership-director. 
  4. ↑ "21st Century Cures Act of 2016". U.S. Congress. https://www.congress.gov/bill/114th-congress/house-bill/6. 
  5. ↑ "NIH Clinical Trials Policy". National Institutes of Health. https://grants.nih.gov/policy/clinical-trials.htm. 
  6. ↑ "eRA Commons". National Institutes of Health. https://era.nih.gov/. 
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