Alternative statistical methods for estimating efficacy of interferon beta-1b for multiple sclerosis clinical trials.

ABSTRACT:

Background

In the randomized study of interferon beta-1b (IFN beta-1b) for multiple sclerosis (MS), it has usually been evaluated the simple annual relapse rate as the study endpoint. This study aimed to investigate the performance of various regression models using information regarding the time to each recurrent event and considering the MS specific data generation process, and to estimate the treatment effect of a MS clinical trial data.

Methods

We conducted a simulation study with consideration of the pathological characteristics of MS, and applied alternative efficacy estimation methods to real clinical trial data, including 5 extended Cox regression models for time-to-event analysis, a Poisson regression model and a Poisson regression model with Generalized Estimating

SUBMITTER: Mieno MN 

PROVIDER: S-EPMC3118202 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature