Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 22, Issue 2, Pages 237-259Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2010.528105
Keywords
Bivariate negative binomial distribution; Likelihood ratio test; Relapsing remitting multiple sclerosis; Sample size; Score test; Wald test
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We use negative binomial (NB) models for the magnetic resonance imaging (MRI)-based brain lesion count data from parallel group (PG) and baseline versus treatment (BVT) trials for relapsing remitting multiple sclerosis (RRMS) patients, and describe the associated likelihood ratio (LR), score, and Wald tests. We perform power analyses and sample size estimation using the simulated percentiles of the exact distribution of the test statistics for the PG and BVT trials. When compared to the corresponding nonparametric test, the LR test results in 30-45% reduction in sample sizes for the PG trials and 25-60% reduction for the BVT trials.
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