Surrogate Endpoints in Clinical Trials¶
Prentice, R. L. (1989). Surrogate Endpoints in Clinical Trials: Definition and Operational Criteria. Statistics in Medicine, 8(4), 431-440.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Proxy–Target Fidelity
- The fidelity is the degree to which the treatment's effect on the surrogate predicts its effect on the outcome — and the formal subtlety the prime names is that a Correlation between surrogate and outcome in untreated populations is not sufficient for fidelity: what is required is that the treatment effect on the surrogate carry the treatment effect on the outcome, which can fail even when surrogate and outcome are tightly correlated at baseline (the Prentice criterion makes this precise).
This sourceDefines the Prentice criterion: a valid surrogate requires the treatment effect on the surrogate to capture the treatment effect on the true endpoint, beyond baseline correlation.
Supported in partVerified against the publisher's abstract
Prentice's abstract states the 'capture' criterion — the surrogate must capture the treatment-true endpoint relationship — backing the claim's core but not its baseline-correlation clause.
“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.”
- The fidelity is the degree to which the treatment's effect on the surrogate predicts its effect on the outcome — and the formal subtlety the prime names is that a Correlation between surrogate and outcome in untreated populations is not sufficient for fidelity: what is required is that the treatment effect on the surrogate carry the treatment effect on the outcome, which can fail even when surrogate and outcome are tightly correlated at baseline (the Prentice criterion makes this precise).
Mechanisms¶
- Developmental Milestone and Biomarker Panel
- Its central hazard is the surrogate itself: a biomarker is only a proxy, and a marker that correlates with receptivity across a study population may not track it in this individual.
This sourceDefines a surrogate endpoint as a proxy and shows that population-level correlation does not ensure that it tracks the relevant outcome or treatment effect for an individual.
- Its central hazard is the surrogate itself: a biomarker is only a proxy, and a marker that correlates with receptivity across a study population may not track it in this individual.
Verification¶
Does it exist? Confirmed. This work's DOI resolves to a registered record, which fixes its identity. That is all it fixes.
Does it back the claim? Read against the text for 1 of 2 citations: 1 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
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