The challenge of comorbidity in clinical trials for multiple sclerosis

Ruth Ann Marrie, Aaron Miller, Maria Pia Sormani, Alan Thompson, Emmanuelle Waubant, Maria Trojano, Paul O'Connor, Stephen Reingold, Jeffrey A. Cohen

Research output: Contribution to journalArticlepeer-review

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 reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies. Conclusion: Our recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to "real world" settings where the MS population commonly has comorbid conditions.
Original languageEnglish
Pages (from-to)1437 - 1445
Number of pages9
JournalNeurology
Volume86
Issue number15
DOIs
Publication statusPublished - Apr 12 2016
Externally publishedYes

ASJC Scopus subject areas

  • Clinical Neurology

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