Big Multiple Sclerosis Data network: an international registry research network.

Autor: Glaser A; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden., Butzkueven H; Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia., van der Walt A; Department of Neurology, The Alfred Hospital, Melbourne, VIC, Australia., Gray O; South Eastern Health and Social Care Trust, Belfast, UK., Spelman T; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.; Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia., Zhu C; Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia., Trojano M; School of Medicine, University 'Aldo Moro', Bari, Italy., Iaffaldano P; Department of Translational Biomedicine and Neurosciences, DiBraiN University of Bari Aldo Moro, Bari, Italy., Battaglia MA; Research Department, Italian Multiple Sclerosis Foundation, Genoa, Italy.; Department of Life Sciences, University of Siena, Siena, Italy., Lucisano G; Department of Translational Biomedicine and Neurosciences, DiBraiN University of Bari Aldo Moro, Bari, Italy.; Center for Outcomes Research and Clinical Epidemiology-CORESEARCH, Pescara, Italy., Vukusic S; Service de Neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, 69677, Bron, France.; INSERM 1028 et CNRS UMR 5292, Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, 69003, Lyon, France.; Université de Lyon, Université Claude Bernard Lyon 1, 69000, Lyon, France.; Eugène Devic EDMUS Foundation Against Multiple Sclerosis, State-Approved Foundation, 69677, Bron, France., Vukusic I; Service de Neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, 69677, Bron, France.; INSERM 1028 et CNRS UMR 5292, Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, 69003, Lyon, France.; Université de Lyon, Université Claude Bernard Lyon 1, 69000, Lyon, France.; Eugène Devic EDMUS Foundation Against Multiple Sclerosis, State-Approved Foundation, 69677, Bron, France., Casey R; Service de Neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, 69677, Bron, France.; INSERM 1028 et CNRS UMR 5292, Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, 69003, Lyon, France.; Université de Lyon, Université Claude Bernard Lyon 1, 69000, Lyon, France.; Eugène Devic EDMUS Foundation Against Multiple Sclerosis, State-Approved Foundation, 69677, Bron, France., Horakova D; Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine Charles University and General University Hospital in Prague, Prague, Czech Republic., Drahota J; Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine Charles University and General University Hospital in Prague, Prague, Czech Republic.; IMPULS Endowment Fund, Prague, Czech Republic., Magyari M; Department of Neurology, Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, 2100, Copenhagen, Denmark., Joensen H; The Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark., Pontieri L; The Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark., Elberling F; The Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark., Klyve P; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden., Mouresan EF; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden., Forsberg L; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden., Hillert J; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden. jan.hillert@ki.se.
Jazyk: angličtina
Zdroj: Journal of neurology [J Neurol] 2024 Jun; Vol. 271 (6), pp. 3616-3624. Date of Electronic Publication: 2024 Apr 01.
DOI: 10.1007/s00415-024-12303-6
Abstrakt: Background: The Big Multiple Sclerosis Data (BMSD) network ( https://bigmsdata.org ) was initiated in 2014 and includes the national multiple sclerosis (MS) registries of the Czech Republic, Denmark, France, Italy, and Sweden as well as the international MSBase registry. BMSD has addressed the ethical, legal, technical, and governance-related challenges for data sharing and so far, published three scientific papers on pooled datasets as proof of concept for its collaborative design.
Data Collection: Although BMSD registries operate independently on different platforms, similarities in variables, definitions and data structure allow joint analysis of data. Certain coordinated modifications in how the registries collect adverse event data have been implemented after BMSD consensus decisions, showing the ability to develop together.
Data Management: Scientific projects can be proposed by external sponsors via the coordinating centre and each registry decides independently on participation, respecting its governance structure. Research datasets are established in a project-to-project fashion and a project-specific data model is developed, based on a unifying core data model. To overcome challenges in data sharing, BMSD has developed procedures for federated data analysis.
Future Perspectives: Presently, BMSD is seeking a qualification opinion from the European Medicines Agency (EMA) to conduct post-authorization safety studies (PASS) and aims to pursue a qualification opinion also for post-authorization effectiveness studies (PAES). BMSD aspires to promote the advancement of real-world evidence research in the MS field.
(© 2024. The Author(s).)
Databáze: MEDLINE
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