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A general framework for the evaluation of clinical trial quality
Vance W Berger1, Sunny Y Alperson
1National Institutes of Health/National Cancer Institute, 6130 Executive Boulevard, MSC-7354, Bethesda, MD 20892-7354 USA. bergerv@mail.nih.gov
Reviews on Recent Clinical Trials
|May 26, 2009
Summary
Current clinical trial quality evaluations are inadequate, allowing flawed research to be funded and published. A robust system must identify, score, and multiply bias risks for accurate trial assessment.
Area of Science:
- Clinical research methodology
- Biomedical ethics
- Evidence-based medicine
Background:
- Inadequate evaluation of clinical trial quality permits flawed studies to progress through funding, approval, publication, and policy-making stages.
- Potential biases can individually invalidate trial results, and new distortion methods may emerge.
- Financial and other vested interests necessitate scrutiny of inadequately reported trial quality aspects.
Purpose of the Study:
- To highlight the deficiencies in current clinical trial quality evaluation methods.
- To propose a more rigorous framework for assessing clinical trial integrity.
Main Methods:
- Critique of existing clinical trial quality assessment approaches.
- Proposal of a novel scoring system for clinical trial bias evaluation.
Main Results:
- Current evaluations are insufficient and fall short of ideal standards.
- A proposed adequate evaluation requires bias enumeration, periodic updates, individual bias scoring (0-100%), substantiated credit, and multiplicative scoring.
Conclusions:
- Existing methods for evaluating clinical trial quality are fundamentally flawed.
- A comprehensive, quantitative approach is necessary to ensure the reliability of clinical trial data and its subsequent use.
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