Bayesian decision theoretic two-stage design in phase II clinical trials with survival endpoint.
Bayesian decision theoretic two-stage design in phase II clinical trials with survival endpoint.
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DOI：
10.1002/sim.4511
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发表时间：
2012-07-30
影响因子：
2
通讯作者：
Schuetze SM
中科院分区：
文献类型：
--
作者：
Zhao L;Taylor JM;Schuetze SM
In this paper, we consider two-stage designs with failure-time endpoints in single arm phase II trials. We propose designs in which stopping rules are constructed by comparing the Bayes risk of stopping at stage one to the expected Bayes risk of continuing to stage two using both the observed data in stage one and the predicted survival data in stage two. Terminal decision rules are constructed by comparing the posterior expected loss of a rejection decision versus an acceptance decision. Simple threshold loss functions are applied to time-to-event data modelled either parametrically or non-parametrically, and the cost parameters in the loss structure are calibrated to obtain desired Type I error and power. We ran simulation studies to evaluate design properties including type I&II errors, probability of early stopping, expected sample size and expected trial duration, and compared them with the Simon two-stage designs and a design which is an extension of the Simon’s designs with time-to-event endpoints. An example based on a recently conducted phase II sarcoma trial illustrates the method.
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