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Due to ethical and economical reasons, sequential single-arm trial designsare used for assessing the therapeutic efficacy of new treatments in phase IItrials. Simon's 2-stage design and Lan-DeMets' $\alpha$-spending functionmethod with O'Brien-Fleming type are widely recognized as the traditionalmethods for futility stopping and efficacy stopping, respectively. Thesemethods have two practical problems, which are the difficulty of interpretationfor stopping under staggered entry and the inflation of error rate due to asmall-sample trial. In this research, we propose the exact sequential designmaking the threshold value for efficacy fixed, and compare with traditionaldesigns in sample size. Since the maximum sample size and average sample numberof the proposed design are generally smaller than those of traditional designscontaining fixed design, the proposed design is expected to be enrolled fewersubjects. In addition, we evaluate several kinds of point estimators andconfidence intervals at the end of trials in the proposed design. If one isconcerned with bias, the bias-adjusted estimator may be better. As for aconfidence interval, the mid-p approach will be a good choice.

Exact sequential single-arm trial design with curtailment for binary endpoint