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[Surrogate endpoints].

Authors: C, Hill;

[Surrogate endpoints].

Abstract

The main endpoint of a phase III trial in oncology must be relevant clinically. In practice, this endpoint is either the disease-free or the overall survival, which requires both long term follow-up and a large number of patients. In phase II trials, it is essential to proceed rapidly, and one therefore uses a surrogate endpoint. Surrogate endpoints are adequate for phase II trials. Their use for phase III trials should be restricted to the rare situations where their validity has been established for the therapeutic and a under study. This surrogate endpoint must be faster to obtain than the clinical endpoint it replaces. Ideally, it should capture all of the treatment effect on the main endpoint, i.e. there should be no effect of the treatment on survival, once the value of the surrogate endpoint is known.

Related Organizations
Keywords

Clinical Trials, Phase II as Topic, Treatment Outcome, Clinical Trials, Phase III as Topic, Neoplasms, Quality of Life, Humans, Reproducibility of Results

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
3
Average
Average
Average
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