Premium
A Bayesian–frequentist two‐stage single‐arm phase II clinical trial design
Author(s) -
Dong Gaohong,
Shih Weichung Joe,
Moore Dirk,
Quan Hui,
Marcella Stephen
Publication year - 2012
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.5330
Subject(s) - frequentist inference , bayesian probability , statistics , frequentist probability , sample size determination , econometrics , type i and type ii errors , bayes factor , bayesian inference , computer science , mathematics
It is well‐known that both frequentist and Bayesian clinical trial designs have their own advantages and disadvantages. To have better properties inherited from these two types of designs, we developed a Bayesian–frequentist two‐stage single‐arm phase II clinical trial design. This design allows both early acceptance and rejection of the null hypothesis ( H 0 ). The measures (for example probability of trial early termination, expected sample size, etc.) of the design properties under both frequentist and Bayesian settings are derived. Moreover, under the Bayesian setting, the upper and lower boundaries are determined with predictive probability of trial success outcome. Given a beta prior and a sample size for stage I, based on the marginal distribution of the responses at stage I, we derived Bayesian Type I and Type II error rates. By controlling both frequentist and Bayesian error rates, the Bayesian‐frequentist two‐stage design has special features compared with other two‐stage designs. Copyright © 2012 John Wiley & Sons, Ltd.