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Surrogate end points: how well do they represent patient-relevant end points?
1Institute for Quality & Efficiency in Health Care, Dillenburger Str. 27, D-51105 Cologne, Germany. marco.jost@iqwig.de
Biomarkers in Medicine
|May 19, 2010
Summary
Surrogate end points in clinical trials can speed drug development but require strict evaluation. Prostate-specific antigen (PSA) in prostate cancer trials is critically reviewed for its validity as a surrogate end point.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Oncology Drug Development
Background:
- Surrogate end points offer earlier measurement and faster therapeutic adjustments in clinical trials.
- Past surrogate end points have sometimes failed to meet expectations, highlighting the need for rigorous validation.
- Prostate-specific antigen (PSA) is frequently used as a surrogate in prostate cancer trials.
Purpose of the Study:
- To critically evaluate the concept of using surrogate end points in clinical trials.
- To assess the suitability of prostate-specific antigen (PSA) as a surrogate end point for prostate cancer.
Main Methods:
- Review of the concept of surrogate end points in clinical research.
- Application of Prentice criteria for evaluating surrogate end points.
- Utilizing a meta-analytic approach to assess prostate-specific antigen (PSA) validity.
Main Results:
- The review emphasizes the importance of strict evaluation criteria for surrogate end points.
- The use of PSA as a surrogate for overall or progression-free survival in prostate cancer trials is discussed.
- The study highlights the potential pitfalls of relying on surrogate end points without robust validation.
Conclusions:
- Surrogate end points, while potentially beneficial, must be rigorously validated to ensure patient-relevant outcomes.
- The evaluation of prostate-specific antigen (PSA) using established criteria is crucial for its reliable use in clinical trials.
- Strict adherence to validation frameworks is essential for maintaining the integrity of clinical trial endpoints.
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