Optimal continuous-monitoring design of single-arm phase II trial based on the simulated annealing method.

ABSTRACT: Simon's two-stage design is commonly used in phase II single-arm clinical trials because of its simplicity and smaller sample size under the null hypothesis compared to the one-stage design. Some studies extend this design to accommodate more interim analyses (i.e., three-stage or four-stage designs). However, most of these studies, together with the original Simon's two-stage design, are based on the exhaustive search method, which is difficult to extend to high-dimensional, general multi-stage designs. In this study, we propose a simulated annealing (SA)-based design to optimize the early stopping boundaries and minimize the expected sample size for multi-stage or continuous monitoring single-arm trials. We compare the results of the SA method, the decision-theoretic method, the predicti

SUBMITTER: Chen N 

PROVIDER: S-EPMC3741066 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature