The challenge of comorbidity in clinical trials for multiple sclerosis

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dc.contributor.authorMarrie, Ruth Ann
dc.contributor.authorMiller, Aaron
dc.contributor.authorSormani, Maria Pia
dc.contributor.authorThompson, Alan
dc.contributor.authorWaubant, Emmanuelle
dc.contributor.authorTrojano, Maria
dc.contributor.authorO'Connor, Paul
dc.contributor.authorReingold, Stephen
dc.contributor.authorCohen, Jeffrey A.
dc.date.accessioned2019-01-24T21:11:56Z
dc.date.available2019-01-24T21:11:56Z
dc.date.issued2016
dc.description.abstractObjective: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.
dc.description.grantingagencyNational Multiple Sclerosis Society (US)
dc.description.grantingagencyECTRIMS
dc.description.grantingagencyDon Paty Career Development Award from the MS Society of Canada
dc.description.grantingagencyManitoba Research Chair from Research Manitoba
dc.description.grantingagencyInternational Advisory Committee on Clinical Trials in Multiple Sclerosis
dc.description.grantingagencyEuropean Committee for Treatment and Research in Multiple Sclerosis
dc.description.grantingagencyUS National Multiple Sclerosis Society
dc.identifier.citationMarrie, R. A., Miller, A., Sormani, M. P., Thompson, A., Waubant, E., … Trojano, M. (2016). The challenge of comorbidity in clinical trials for multiple sclerosis. Neurology, 86(15), 1437–1445. https://doi.org/10.1212/wnl.0000000000002471
dc.identifier.doi10.1212/WNL.0000000000002471
dc.identifier.doihttp://dx.doi.org/10.11575/PRISM/35782
dc.identifier.issn0028-3878
dc.identifier.urihttp://hdl.handle.net/1880/109523
dc.publisherLIPPINCOTT WILLIAMS & WILKINS
dc.publisher.facultyCumming School of Medicine
dc.publisher.hasversionPublished version
dc.publisher.policyhttp://www.neurology.org/open-access/neuro
dc.rights© 2016 American Academy of Neurology
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectMedical/Systematic disease
dc.subjectMultiple sclerosis
dc.subjectClinical trials Methodology/study design
dc.titleThe challenge of comorbidity in clinical trials for multiple sclerosis
dc.typeReview
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