Stata command for calculating adverse event and efficacy stopping boundaries for phase II single-arm trials

• Autores: Bryan M. Fellman
• Localización: The Stata journal, ISSN 1536-867X, Vol. 14, Nº. 2, 2014, págs. 407-417
• Idioma: inglés
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• Resumen

  • 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.