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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/11049

Title: A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials
Authors: Molenberghs, Geert
Burzykowski, Tomasz
Alonso Abad, Ariel
Assam Nkouibert, Pryseley
Tilahun, Abel
Buyse, Marc E.
Issue Date: 2010
Abstract: For a number of reasons, surrogate endpoints are considered instead of the so-called true endpoint in clinical studies, especially when such endpoints can be measured earlier, and/or with less burden for patient and experimenter. Surrogate endpoints may occur more frequently than their standard counterparts. For these reasons, it is not surprising that the use of surrogate endpoints in clinical practice is increasing. Building on the seminal work of Prentice(1) and Freedman et al.,(2) Buyse et al.(3) framed the evaluation exercise within a meta-analytic setting, in an effort to overcome difficulties that necessarily surround evaluation efforts based on a single trial. In this article, we review the meta-analytic approach for continuous outcomes, discuss extensions to non-normal and longitudinal settings, as well as proposals to unify the somewhat disparate collection of validation measures currently on the market. Implications for design and for predicting the effect of treatment in a new trial, based on the surrogate, are discussed. A case study in schizophrenia is analysed.
Notes: [Molenberghs, Geert] Hasselt Univ, Ctr Stat, B-3590 Diepenbeek, Belgium. [Molenberghs, Geert] Katholieke Univ Leuven, Leuven, Belgium. [Buyse, Marc] Int Inst Drug Dev, Ottignies, Belgium. geert.molenberghs@uhasselt.be
URI: http://hdl.handle.net/1942/11049
DOI: 10.1177/0962280209105015
ISI #: 000279354100002
ISSN: 0962-2802
Category: A1
Type: Journal Contribution
Validation: ecoom, 2011
Appears in Collections: Research publications

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