Estimation of sample size in randomized controlled trials in multiple sclerosis studying annualized relapse rates: A systematic review

In multiple sclerosis (MS) studies, the most appropriate model for the distribution of the number of relapses was shown to be the negative binomial (NB) distribution.To determine whether the sample-size estimation (SSE) and the analysis of annualized relapse rates (ARRs) in randomized controlled trials (RCTs) were aligned and compare the SSE between normal and NB distributions.Systematic review of phase 3 and 4 RCTs for which the primary...