Recurrent disability progression endpoints in multiple sclerosis clinical trials.

ABSTRACT:

Background

The current standard endpoint to assess disability accumulation in multiple sclerosis (MS) clinical trials is the time to the first confirmed disability progression, which excludes subsequent progression events. Including recurrent progression events may permit a more comprehensive assessment of treatment effects on disability progression.

Objective

To propose a definition of recurrent disability progression events and to compare time-to-first and recurrent event analysis.

Methods

Recurrent disability progression events were defined by expanding the recommended first event definition. Marginal recurrent event methods (negative binomial model, Lin-Wei-Yang-Ying model) were compared with Cox regression in data from three randomized controlled trials in relaps

SUBMITTER: Buhler A 

PROVIDER: S-EPMC9896250 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature