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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/666

Title: The validation of surrogate endpoints by using data from randomized clinical trials: a case-study in advanced colorectal cancer
Authors: Burzykowski, Tomasz
Molenberghs, Geert
Buyse, Marc E.
Keywords: Surrogate Markers
Clinical trials
Survival analysis
Issue Date: 2004
Citation: Journal of the Royal Statistical Society A, 167(1). p. 103-124
Abstract: In many therapeutic areas, the identification and validation of surrogate end points is of prime interest to reduce the duration and/or size of clinical trials. Buyse and co-workers and Burzykowski and co-workers have proposed a validation strategy for end points that are either normally distributed or (possibly censored) failure times. In this paper, we address the problem of validating an ordinal categorical or binary end point as a surrogate for a failure time true end point. In particular, we investigate the validity of tumour response as a surrogate for survival time in evaluating fluoropyrimidine-based experimental therapies for advanced colorectal cancer. Our analysis is performed on data from 28 randomized trials in advanced colorectal cancer, which are available through the Meta-Analysis Group in Cancer.
URI: http://hdl.handle.net/1942/666
DOI: 10.1111/j.1467-985X.2004.00293.x
ISI #: 000187343900006
ISSN: 1467-985X
Category: A1
Type: Journal Contribution
Validation: ecoom, 2005
Appears in Collections: Research publications

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