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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 |
Issue Date: | 2004 | Publisher: | BLACKWELL PUBL LTD | Source: | 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. | Keywords: | copula model; meta-analysis; plackett copula; surrogate end point; survival; tumour response; two-stage model | Document URI: | http://hdl.handle.net/1942/666 | ISSN: | 0964-1998 | e-ISSN: | 1467-985X | DOI: | 10.1111/j.1467-985X.2004.00293.x | ISI #: | 000187343900006 | Rights: | (C) 2004 Royal Statistical Society | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2005 |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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burt10.pdf | Published version | 230.7 kB | Adobe PDF | View/Open |
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