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Title of Journal: Int J Clin Oncol

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Abbravation: International Journal of Clinical Oncology

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Springer Japan

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DOI

10.1016/j.aim.2005.05.014

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1437-7772

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Metaanalysis for the evaluation of surrogate endp

Authors: Qian Shi Daniel J Sargent
Publish Date: 2009/04/24
Volume: 14, Issue: 2, Pages: 102-111
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Abstract

The identification and validation of putative surrogate endpoints in oncology is a great challenge to medical investigators statisticians and regulators A putative surrogate endpoint must be validated at both individuallevel and triallevel before it can be used to replace the clinical endpoint in a future clinical trial Recently metaanalytic methods for evaluating potential surrogates have become widely accepted in cancer clinical trials In this review after addressing multiple complications and general issues surrounding surrogate endpoints we review various proposed and adopted metaanalytic methodologies pertaining to the application of these methods to oncology clinical trials with different tumor types In oncology several applications have successfully identified useful surrogates For example diseasefree survival and progressionfree survival have been validated through metaanalyses as acceptable surrogates for overall survival in adjuvant colon cancer and advanced colorectal cancer respectively We also discuss several limitations of surrogate endpoints including the critical issues that the extrapolation of the validity of a surrogate is always contextdependent and that such extrapolation should be exercised with caution

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