Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/1971
Title: | Surrogate threshold effect: An alternative measure for meta-analytic surrogate endpoint validation | Authors: | BURZYKOWSKI, Tomasz BUYSE, Marc |
Issue Date: | 2006 | Publisher: | JOHN WILEY & SONS INC | Source: | PHARMACEUTICAL STATISTICS, 5(3). p. 173-186 | Abstract: | In many therapeutic areas, the identification and validation Of surrogate endpoints is of prime interest to reduce the duration and/or size of clinical trials. Buyse et al. [Biostatistics 2000; 1:49-67] proposed a meta-analytic approach to the validation. In this approach, the validity of a surrogate is quantified by the coefficient of determination R-trial(2) obtained from a model, which allows for prediction of the treatment effect on the endpoint of interest ('true' endpoint) from the effect on the surrogate. One problem related to the use of R-trial(2) is the difficulty in interpreting its value. To address this difficulty, in this paper we introduce a new concept, the so-called surrogate threshold effect (STE), defined as the minimum treatment effect on the surrogate necessary to predict a non-zero effect on the true endpoint. One of its interesting features, apart from providing information relevant to the practical use of a surrogate endpoint, is its natural interpretation from a clinical point of view. Copyright (C) 2006 John Wiley & Sons, Ltd. | Notes: | Hasselt Univ, Ctr Stat, B-3590 Diepenbeek, Belgium. Int Inst Drug Dev, Brussels, Belgium.Burzykowski, T, Hasselt Univ, Ctr Stat, Agoralaan Bldg D, B-3590 Diepenbeek, Belgium.tomasz.burzykowski@uhasselt.be | Keywords: | surrogate endpoint; validation; meta-analysis; two-stage model; prediction | Document URI: | http://hdl.handle.net/1942/1971 | ISSN: | 1539-1604 | e-ISSN: | 1539-1612 | DOI: | 10.1002/pst.207 | ISI #: | 000240838800003 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2007 |
Appears in Collections: | Research publications |
Show full item record
SCOPUSTM
Citations
108
checked on Sep 3, 2020
WEB OF SCIENCETM
Citations
150
checked on Oct 14, 2024
Page view(s)
90
checked on May 23, 2023
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.