OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis.

Chu-Yueh GuoMatthew CranerEd WaddinghamAleisha MillerAna CaveyStewart WebbCheryl HemingwayJeremy HobartNikos EvangelouNeil ScoldingDavid RogRichard NicholasMonica MartaCamilla BlainCarolyn Anne YoungHelen L FordPaul M Matthews

Published in: BMJ open (2021)

This study has ethical permission (London City and East; Ref 19/LO/0064). Potential concerns around data storage and sharing are mitigated by the separation of identifiable data from all other clinical data, and limiting access to any identifiable data. The results of this study will be disseminated via publication. Participants provide consent for anonymised data to be shared for further research use, further enhancing the value of the study.

Keyphrases

multiple sclerosis
electronic health record
study protocol
big data
clinical trial
mass spectrometry
ms ms
emergency department
climate change
drug induced