Group sequential clinical trial designs for normally distributed outcome variables

• Autores: Michael J. Grayling, James M. S Wason, Adrian P. Mander
• Localización: The Stata journal, ISSN 1536-867X, Vol. 18, Nº. 2, 2018, págs. 416-431
• Idioma: inglés
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• Resumen

  • In a group sequential clinical trial, accumulated data are analyzed at numerous time points to allow early decisions about a hypothesis of interest. These designs have historically been recommended for their ethical, administrative, and economic benefits. In this article, we first discuss a collection of new commands for computing the stopping boundaries and required group size of various classical group sequential designs, assuming a normally distributed outcome variable. Then, we demonstrate how the performance of several designs can be compared graphically.