Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study

IntroductionOptimise:MS is an observational pharmacovigilance study aimed at characterizing the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in a real world population. The study will categorize and quantify the occurrence of serious adverse events (SAEs) in a coh...

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Bibliographic Details
Main Authors: Ed Waddingham, Aleisha Miller, Ruth Dobson, Paul M. Matthews
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-03-01
Series:Frontiers in Neurology
Subjects:
real-world data
cohort study
signal detection
multiple sclerosis
pharmacovigilance
statistical analysis plan
Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2022.799531/full

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