Survival Analysis in the Regulatory Setting
The powerful methods for analyzing survival data (particularly censored survival data) that were introduced in the late 1960’s and early 1970’s represented major advances in the statistical assessment of such data. It is important to recognize, however, that these may not always be most appropriate to address the fundamental study question in any situation in which time-to-event techniques could be applied. In this paper, several such situations are considered, and the particular implications for regulatory decision-making are discussed.
KeywordsComposite Endpoint Rejection Episode Proportional Hazard Assumption Regulatory Setting Sepsis Syndrome
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