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Title: | The meta-analytic framework for the evaluation of surrogate endpoints in clinical trials | Authors: | MOLENBERGHS, Geert BURZYKOWSKI, Tomasz ALONSO ABAD, Ariel ASSAM NKOUIBERT, Pryseley TILAHUN ESHETE, Abel BUYSE, Marc |
Issue Date: | 2008 | Publisher: | ELSEVIER SCIENCE BV | Source: | JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 138(2). p. 432-449 | 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 [ 1989. Surrogate endpoints in clinical trials: definitions and operational criteria. Statist. Med. 8, 43 1-440] and Freedman et a]. [ 1992. Statistical validation of intermediate endpoints for chronic diseases. Statist. Med. 11, 167-178], Buyse et al. [2000. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics 1, 49-67] 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 paper, 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. Two case studies are analyzed, one in schizophrenia and one in opthalmology. (C) 2007 Elsevier B.V. All rights reserved. | Notes: | Hasselt Univ, Ctr Stat, Diepenbeek, Belgium. Int Inst Drug Dev, Louvain, Belgium.Molenbergh, G, Hasselt Univ, Ctr Stat, Diepenbeek, Belgium.geert.molenberghs@uhasselt.be | Keywords: | hierarchical model; likelihood reduction factor; meta-analysis; random-effects model; surrogate endpoint; surrogate threshold effect;hierarchical model; likelihood reduction factor; meta-analysis; random-effects model; surrogate endpoint; surrogate threshold effect | Document URI: | http://hdl.handle.net/1942/8005 | ISSN: | 0378-3758 | e-ISSN: | 1873-1171 | DOI: | 10.1016/j.jspi.2007.06.005 | ISI #: | 000253067200010 | Rights: | © 2007 Elsevier B.V. All rights reserved. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2009 |
Appears in Collections: | Research publications |
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The Meta-analytic Framework for the Evaluation.pdf | Peer-reviewed author version | 225.37 kB | Adobe PDF | View/Open |
a.pdf Restricted Access | Published version | 239.85 kB | Adobe PDF | View/Open Request a copy |
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