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Rescuing clinical trials in the United States and beyond: a call for action
Zubin J Eapen1, John P Vavalle, Christopher B Granger
1Duke Clinical Research Institute, Durham, NC 27715, USA. zubin.eapen@duke.edu
American Heart Journal
|May 28, 2013
Summary
US participation in global clinical trials faces significant financial, regulatory, and cultural hurdles. Revitalizing clinical research requires both incremental and transformative changes to ensure trial results benefit American patients.
Area of Science:
- Clinical research
- Health policy
- Multinational collaboration
Background:
- US participation and performance in multinational clinical trials are declining due to financial, regulatory, and cultural challenges.
- This decline raises concerns about the applicability of global trial results to American patients and healthcare systems.
- A decline in clinical trial participation impacts the broader research enterprise.
Purpose of the Study:
- To identify and summarize adverse trends affecting US involvement in multinational clinical trials.
- To analyze the underlying issues contributing to these adverse trends.
- To propose potential solutions for revitalizing US participation in clinical research.
Main Methods:
- Convened stakeholders from academia, industry, and government.
- Summarized proceedings from a consensus-building meeting.
- Addressed key issues and potential solutions through discussion and analysis.
Main Results:
- Identified significant financial, regulatory, and cultural barriers hindering US participation.
- Highlighted the uncertainty in applying multinational trial outcomes to US contexts.
- Outlined the need for both incremental and transformative changes in clinical research.
Conclusions:
- Urgent, multifaceted solutions are required to reverse negative trends in US clinical trial participation.
- Collaboration among academia, industry, and government is crucial for addressing these challenges.
- Revitalizing the clinical trial enterprise is essential for advancing medical knowledge and patient care.
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