Validity and power of minimization algorithm in longitudinal analysis of clinical trials.

ABSTRACT: We studied the validity of longitudinal statistical inferences of clinical trials using minimization, a dynamic randomization algorithm designed to minimize treatment imbalance for prognostic factors. Repeated measures analysis of covariance and the random intercept and slope models, were used to simulate longitudinal clinical trials randomized by minimization or simple randomization. The simulations represented a wide range of analyses in real-world trials, including missing data caused by dropouts, unequal allocation of treatment arms, and efficacy analyses on either the original outcome or its change from baseline. We also analyzed the database from the Dominantly Inherited Alzheimer Network (DIAN), and used the estimated parameters to simulate the ongoing DIAN trial. Our analyses demon

SUBMITTER: Weng H 

PROVIDER: S-EPMC5730087 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature