Modified Simon's minimax and optimal two-stage designs for single-arm phase II cancer clinical trials.

ABSTRACT: Simon's two-stage design and the admissible two-stage design have been commonly used in practice for single-arm phase II clinical trials when the primary endpoint is binary. The ethical benefit of the two-stage design over the single-stage design is attained by the early termination of the trial when the treatment seems to be inactive. While Simon's optimal design is the two-stage design that minimizes the expected number of subjects under the null hypothesis, the probability of falsely declaring futility after the first stage frequently seems undesirably high. In Simon's minimax design, however, it is often the case that a high proportion of the total planned subjects are evaluated in the first stage, and thus the ethical benefit may not be achieved. In this paper, we propose modified min

SUBMITTER: Kim J 

PROVIDER: S-EPMC6611508 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature