Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: a tutorialZohar, S., Teramukai, S. and Zhou, Y. (2008) Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: a tutorial. Contemporary Clinical Trials, 29 (4). pp. 608-16. ISSN 1551-7144 Full text not archived in this repository. It is advisable to refer to the publisher's version if you intend to cite from this work. See Guidance on citing. To link to this item DOI: 10.1016/j.cct.2007.11.005 Abstract/SummaryThe aim of phase II single-arm clinical trials of a new drug is to determine whether it has sufficient promising activity to warrant 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.
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