Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: A tutorial
Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: A tutorial
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DOI:
10.1016/j.cct.2007.11.005
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发表时间:
2008-07-01
影响因子:
2.2
通讯作者:
Zhou, Yinghui
中科院分区:
文献类型:
--
作者:
Zohar, Sarah;Teramukai, Satoshi;Zhou, Yinghui
The aim of phase H single-arm clinical trials of a new drug is to determine whether it has sufficient promising activity to wan-ant its further development. For the last several years Bayesian statistical methods have been proposed and used. Bayesian approaches are ideal for earlier phase trials as they take into account information that accrues during a trial. Predictive probabilities are then updated and so become more accurate as the trial progresses. Suitable priors can act as pseudo samples, which make small sample clinical trials more informative. Thus patients have better chances to receive better treatments. The goal of this paper is to provide a tutorial for statisticians who use Bayesian methods for the first time or investigators who have some statistical background. In addition, real data from three clinical trials are presented as examples to illustrate how to conduct a Bayesian approach for phase II single-arm clinical trials with binary outcomes. (c) 2007 Elsevier Inc. All rights reserved.