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Evaluating surrogate endpoints, prognostic markers, and predictive markers: Some simple themes.
Stuart G Baker1, Barnett S Kramer2
1Division of Cancer Prevention, National Cancer Institute, Bethesda MD, USA sb16i@nih.gov.
Clinical Trials (London, England)
|November 12, 2014
Summary
This study outlines simple themes for evaluating surrogate endpoints and prognostic/predictive markers. These guidelines help in understanding treatment effects and selecting appropriate markers for clinical decisions.
Area of Science:
- Biostatistics
- Clinical Trial Design
- Pharmacometrics
Background:
- Surrogate endpoints predict treatment effects on true health outcomes.
- Prognostic markers predict event risk in control groups.
- Predictive markers forecast treatment effects in patient subgroups.
Purpose of the Study:
- To provide a framework for evaluating surrogate endpoints.
- To discuss the utility of prognostic and predictive markers.
- To simplify the assessment of markers in clinical research.
Main Methods:
- Discussion organized thematically for each marker type.
- Exploration of non-statistical considerations for surrogate endpoints.
- Application of decision analysis for prognostic marker evaluation.
Main Results:
- Surrogate endpoint evaluation involves "fundamentally an extrapolation."
- Prognostic marker assessment benefits from "decision analysis to the rescue."
- Predictive markers offer "the appeal of simplicity" via single randomized trials.
Conclusions:
- Simple themes guide the evaluation of surrogate endpoints.
- Guidelines aid in assessing prognostic markers.
- Frameworks support the use of predictive markers for treatment selection.
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