Surrogate endpoints in clinical trials: Definition and operational criteria

Surrogate endpoints in clinical trials: Definition and operational criteria I discuss the idea of using surrogate endpoints in the context of clinical trials to compare two or more treatments or interventions in respect to some ‘true’ endpoint, typically a disease occurrence. In order that treatment comparison based on a surrogate response variable have a meaningful implication for the corresponding true endpoint treatment comparison, a rather restrictive criterion is proposed for use of the adjective ‘surrogate’. Specifically, I propose that a surrogate for a true endpoint yield a valid test of the null hypothesis of no association between treatment and the true response. This criterion essentially requires the surrogate variable to ‘capture’ any relationship between the treatment and the true endpoint, a notion that can be operationalized by requiring the true endpoint rate at any follow‐up time to be independent of treatment, given the preceding history of the surrogate variable. I then discuss this operational criterion in the examples of the accompanying papers1–3 and in the setting of trials aimed at the primary and secondary prevention of cancer. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Statistics in Medicine Wiley

Surrogate endpoints in clinical trials: Definition and operational criteria

Statistics in Medicine, Volume 8 (4) – Apr 1, 1989

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Publisher
Wiley
Copyright
"Copyright © 1989 Wiley Subscription Services, Inc., A Wiley Company"
ISSN
0277-6715
eISSN
1097-0258
D.O.I.
10.1002/sim.4780080407
Publisher site
See Article on Publisher Site

Abstract

I discuss the idea of using surrogate endpoints in the context of clinical trials to compare two or more treatments or interventions in respect to some ‘true’ endpoint, typically a disease occurrence. In order that treatment comparison based on a surrogate response variable have a meaningful implication for the corresponding true endpoint treatment comparison, a rather restrictive criterion is proposed for use of the adjective ‘surrogate’. Specifically, I propose that a surrogate for a true endpoint yield a valid test of the null hypothesis of no association between treatment and the true response. This criterion essentially requires the surrogate variable to ‘capture’ any relationship between the treatment and the true endpoint, a notion that can be operationalized by requiring the true endpoint rate at any follow‐up time to be independent of treatment, given the preceding history of the surrogate variable. I then discuss this operational criterion in the examples of the accompanying papers1–3 and in the setting of trials aimed at the primary and secondary prevention of cancer.

Journal

Statistics in MedicineWiley

Published: Apr 1, 1989

Keywords: ; ; ; ;

References

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