Estimating significance level and power comparisons for testing multiple endpoints in clinical trials
J Gong, JC Pinheiro, DL DeMets - Controlled clinical trials, 2000 - Elsevier
Clinical trials generally include several outcome measures of interest for assessing
treatment efficacy and harm. Traditionally a single measure, the primary outcome, is
selected and used as the basis for the design, including sample size and power. Secondary
outcomes are then generally ordered with respect to their clinical relevance and importance.
While this has become the traditional paradigm, recent trials have suggested the need for
additional approaches. In this setting, two outcomes are viewed as key, either one being …
treatment efficacy and harm. Traditionally a single measure, the primary outcome, is
selected and used as the basis for the design, including sample size and power. Secondary
outcomes are then generally ordered with respect to their clinical relevance and importance.
While this has become the traditional paradigm, recent trials have suggested the need for
additional approaches. In this setting, two outcomes are viewed as key, either one being …