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DC Field | Value | Language |
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dc.contributor.author | MOLENBERGHS, Geert | - |
dc.contributor.author | BURZYKOWSKI, Tomasz | - |
dc.contributor.author | ALONSO ABAD, Ariel | - |
dc.contributor.author | ASSAM NKOUIBERT, Pryseley | - |
dc.contributor.author | TILAHUN ESHETE, Abel | - |
dc.contributor.author | BUYSE, Marc | - |
dc.date.accessioned | 2008-03-17T09:11:35Z | - |
dc.date.available | NO_RESTRICTION | - |
dc.date.issued | 2008 | - |
dc.identifier.citation | JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 138(2). p. 432-449 | - |
dc.identifier.issn | 0378-3758 | - |
dc.identifier.uri | http://hdl.handle.net/1942/8005 | - |
dc.description.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. | - |
dc.description.sponsorship | We gratefully acknowledge support from Belgian IUAP/PAI network “Statistical Techniques and Modeling for Complex Substantive Questions with Complex Data” | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE BV | - |
dc.rights | © 2007 Elsevier B.V. All rights reserved. | - |
dc.subject.other | hierarchical model; likelihood reduction factor; meta-analysis; random-effects model; surrogate endpoint; surrogate threshold effect | - |
dc.subject.other | hierarchical model; likelihood reduction factor; meta-analysis; random-effects model; surrogate endpoint; surrogate threshold effect | - |
dc.title | The meta-analytic framework for the evaluation of surrogate endpoints in clinical trials | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 449 | - |
dc.identifier.issue | 2 | - |
dc.identifier.spage | 432 | - |
dc.identifier.volume | 138 | - |
local.format.pages | 18 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.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 | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.bibliographicCitation.oldjcat | A1 | - |
dc.identifier.doi | 10.1016/j.jspi.2007.06.005 | - |
dc.identifier.isi | 000253067200010 | - |
item.accessRights | Open Access | - |
item.validation | ecoom 2009 | - |
item.fulltext | With Fulltext | - |
item.fullcitation | MOLENBERGHS, Geert; BURZYKOWSKI, Tomasz; ALONSO ABAD, Ariel; ASSAM NKOUIBERT, Pryseley; TILAHUN ESHETE, Abel & BUYSE, Marc (2008) The meta-analytic framework for the evaluation of surrogate endpoints in clinical trials. In: JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 138(2). p. 432-449. | - |
item.contributor | MOLENBERGHS, Geert | - |
item.contributor | BURZYKOWSKI, Tomasz | - |
item.contributor | ALONSO ABAD, Ariel | - |
item.contributor | ASSAM NKOUIBERT, Pryseley | - |
item.contributor | TILAHUN ESHETE, Abel | - |
item.contributor | BUYSE, Marc | - |
crisitem.journal.issn | 0378-3758 | - |
crisitem.journal.eissn | 1873-1171 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
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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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