The challenge of comorbidity in clinical trials for multiple sclerosis

Neurology
Ruth Ann Marrieattendees of the International Workshop on Comorbidity in Multiple Sclerosis

Abstract

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

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Citations

Mar 25, 2017·Current Opinion in Neurology·Alan J Thompson
Apr 26, 2018·Multiple Sclerosis : Clinical and Laboratory Research·Ruth Ann Marrie, Xavier Montalban
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Jul 14, 2019·Neurology·Carrie M Hersh, Ruth Ann Marrie
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Sep 26, 2020·Frontiers in Neurology·Melinda Magyari, Per Soelberg Sorensen
Mar 18, 2017·Nature Reviews. Neurology·Ruth Ann Marrie
Apr 6, 2019·Cephalalgia : an International Journal of Headache·Ishaq Abu-ArafehUNKNOWN Clinical Trials Standing Committee and the Child and Adolescent Standing Committee of the International Headache Society
Dec 22, 2016·International Journal of MS Care·Afolasade FakoladeMarcia Finlayson
Oct 5, 2016·Journal of Neurology·Anja ThormannPer Soelberg Sørensen
Jan 1, 2021·Seminars in Arthritis and Rheumatism·Bethea A KleykampRobert H Dworkin
Sep 4, 2020·Journal of Neurology·Lara Marie Pangan LoIngrid van der Mei

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Methods Mentioned

BETA
pharmacotherapy

Software Mentioned

PRECIS
Pragmatic Explanatory Continuum Index Summary ( PRECIS )

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