Many programs and functions in statistical packages focus on the final stage of clinical trials, that is, the data analysis. In this article, I aim to assist in the early stages of clinical trials, specifically, the design of phase II single-arm trials. I present the new command stopbound, which calculates stopping boundaries and operating characteristics based on monitoring an adverse event, efficacy, or an adverse event and efficacy.
ThallP. F., SimonR. M., and EsteyE. H.1995. Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Statistics in Medicine14: 357–379.
2.
ThallP. F., SimonR. M., and EsteyE. H.1996. New statistical strategy for monitoring safety and efficacy in single-arm clinical trials. Journal of Clinical Oncology14: 296–303.
3.
ThallP. F., and SungH.-G.1998. Some extensions and applications of a Bayesian strategy for monitoring multiple outcomes in clinical trials. Statistics in Medicine17: 1563–1580.
