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Surrogate end points: hopes and perils
Ariel Alonso1, Geert Molenberghs
1Center for Statistics, Hasselt University Building D, 3590 Diepenbeek, Belgium. ariel.alonso@uhasselt.be.
Expert Review of Pharmacoeconomics & Outcomes Research
|June 10, 2010
Summary
Surrogate end points improve clinical trial efficiency and reduce costs. This discussion focuses on validation strategies for these crucial markers in drug development.
Area of Science:
- Clinical Pharmacology
- Biostatistics
- Drug Development
Background:
- Rising drug development costs necessitate greater efficiency in candidate selection.
- Surrogate end points offer potential to shorten clinical trials and mitigate ethical concerns associated with direct clinical outcome measurement.
- Historical controversies surrounding surrogate end points underscore the need for rigorous validation.
Purpose of the Study:
- To discuss proposed validation strategies for surrogate end points.
- To explore the future role and application of surrogate end points in clinical research.
Main Methods:
- Review of recently proposed validation strategies for surrogate end points.
- Discussion of the evolving landscape and future directions for surrogate end point utilization.
Main Results:
- Growing consensus favors the use of only validated surrogate end points.
- Emerging validation strategies aim to enhance the reliability and acceptance of surrogate end points.
Conclusions:
- Validated surrogate end points are essential for efficient and ethical clinical trials.
- Continued development and application of robust validation methods will shape the future of drug development.
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