Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test

Title
Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test
Author(s)
곽민정정신호[정신호]
Keywords
FOLLOW-UP; SURVIVAL
Issue Date
201405
Publisher
WILEY-BLACKWELL
Citation
STATISTICS IN MEDICINE, v.33, no.12, pp.2004 - 2016
Abstract
Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single-arm phase II clinical trials with right censored survival time responses where the ordinary one-sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two-stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two-stage designs, which minimize the maximal sample size, are also determined. Optimal and minimax designs for a range of design parameters are tabulated along with examples. Copyright (c) 2013 John Wiley & Sons, Ltd.
URI
http://hdl.handle.net/YU.REPOSITORY/32162http://dx.doi.org/10.1002/sim.6073
ISSN
0277-6715
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이과대학 > 통계학과 > Articles
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