The challenge of comorbidity in clinical trials for multiple sclerosis.

ABSTRACT:

Objective

We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS).

Methods

We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS.

Results

We recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporti

SUBMITTER: Marrie RA 

PROVIDER: S-EPMC4831041 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature