The evaluation of surrogate endpoints.
type: Item
instance of: scholarly article
title: The evaluation of surrogate endpoints.
zbMATH Open document ID: 1078.62113
published in: Statistics for Biology and Health
publication date: 2005-04-26T00:00:00Z
review text: This recently appeared volume deals with the potentials and limitations of surrogate endpoints in clinical studies. In spite of some erroneous and momentous results in the past based on invalid surrogate endpoints there persists the need of their implementation in clinical trials, e.g., when the true endpoint might be difficult to use or accelerated approval of a new drug is an imperative. This multi\,-\,author monograph contributes to the evaluation of surrogate endpoints a comprehensive overview of statistical modeling and applications accounting also positions taken by the pharmaceutical industry and regulatory authorities (Chapter 2: ``Setting the Scene''; Chapter 3: ``Regulatory Aspects in Using Surrogate Markers in Clinical Trials''). Furthermore, the motivation for the use of surrogates, validation and assessment of the quality of a surrogate as well as its usage for prediction of the true outcome are dealt with in this book. To specify a good surrogate, Prentice's criteria serve as definition and provide operational criteria for the validation of a surrogate endpoint. Starting from the case of a single trial and a single surrogate, different measures are introduced to asses the quality of the surrogate and its association to the true endpoint at the individual as well as at the trial level. See Chapter 5 on ``The History of Surrogate Endpoint Validation'', where the results are described under the assumption of the same data type for both binary and normal endpoints; and see also Chapter 6 on ``Validation Using Single-trial Data: Mixed Binary and Continuous Outcomes'', which tackles mixed binary and continuous outcomes. In Chapter 7 (``A Meta-Analytic Validation Framework for Continuous Outcomes''), the model for normally distributed endpoints is amplified to a meta-analytic or hierarchical two-stage model based on fixed-effects as well as a random-effects representations. Corresponding measures for the assessment of the quality of the surrogate at the indiv…
Mathematics Subject Classification ID: 62P10
Mathematics Subject Classification ID: 62-06
Mathematics Subject Classification ID: 00B15
Mathematics Subject Classification ID: 62J99
Mathematics Subject Classification ID: 62-02
zbMATH DE Number: 2161900
MaRDI profile type: Publication
full work available at URL: b138566
OpenAlex ID: W1558155053
DOI: 10.1007/B138566
description: scientific article; zbMATH DE number 2161900