[Biostatistical Methods for Understanding the Principle of Randomized Controlled Trials].

Abstract

Knowledge of statistics is essential for understanding the evidence from clinical trials. In this paper, the principles of blinding, FAS-ITT, pre-specified endpoints, subgroup analysis, missing values, sample size computation, applicability of global studies, non-inferiority trials, and meta-analysis are described. Moreover, the statistical aspects of the recent large-scale clinical trial regarding aducanumab as an Alzheimer s disease treatment will be discussed.