Document details for 'Statistical approaches for evaluating surrogate outcomes in clinical trials: a systematic review'

Authors Ensor, H, Lee, R., Sudlow, C. and Weir, C.J.
Publication details Journal of Biopharmaceutical Statistics. Taylor and Francis/CRC Press.
Publisher details Taylor and Francis/CRC Press
Keywords Surrogate evaluation, Literature review, Methodology
Abstract The use of surrogate outcomes that predict treatment effect on an unobserved true outcome may have substantial economic and ethical advantages, through reducing the length and size of clinical trials. There has been extensive investigation of the best means of evaluating putative surrogates. We present a systematic review on the evolution of statistical methods for validating surrogates starting from the defining paper of Prentice (1989). We highlight the fundamental differences in the current statistical evaluation approaches, their advantages and disadvantages, and examine the understanding and perceptions of investigators in this area.
Last updated 2017-09-05

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