Optimizing the data combination rule for seamless phase II/III clinical trials.

ABSTRACT: We consider seamless phase II/III clinical trials that compare K treatments with a common control in phase II then test the most promising treatment against control in phase III. The final hypothesis test for the selected treatment can use data from both phases, subject to controlling the familywise type I error rate. We show that the choice of method for conducting the final hypothesis test has a substantial impact on the power to demonstrate that an effective treatment is superior to control. To understand these differences in power, we derive decision rules maximizing power for particular configurations of treatment effects. A rule with such an optimal frequentist property is found as the solution to a multivariate Bayes decision problem. The optimal rules that we derive depend on the a

SUBMITTER: Hampson LV 

PROVIDER: S-EPMC4288236 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature