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

Multiple sclerosis Patient data network Patient registries Real-world evidence

Journal

Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161

Informations de publication

Date de publication:
01 Apr 2024
Historique:
received: 18 12 2023
accepted: 05 03 2024
revised: 29 02 2024
medline: 2 4 2024
pubmed: 2 4 2024
entrez: 1 4 2024
Statut: aheadofprint

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND 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 METHODS
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 UNASSIGNED
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 CONCLUSIONS
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.

Identifiants

DOI: 10.1007/s00415-024-12303-6 PMID: 38561543
pubmed: 38561543
doi: 10.1007/s00415-024-12303-6
pii: 10.1007/s00415-024-12303-6
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Anna Glaser (A)

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

Helmut Butzkueven (H)

Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.

Anneke van der Walt (A)

Department of Neurology, The Alfred Hospital, Melbourne, VIC, Australia.

Orla Gray (O)

South Eastern Health and Social Care Trust, Belfast, UK.

Tim Spelman (T)

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.
Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.

Chao Zhu (C)

Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.

Maria Trojano (M)

School of Medicine, University "Aldo Moro", Bari, Italy.

Pietro Iaffaldano (P)

Department of Translational Biomedicine and Neurosciences, DiBraiN University of Bari Aldo Moro, Bari, Italy.

Mario A Battaglia (MA)

Research Department, Italian Multiple Sclerosis Foundation, Genoa, Italy.
Department of Life Sciences, University of Siena, Siena, Italy.

Giuseppe 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.

Sandra 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.

Irena 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.

Romain 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.

Dana 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.

Jiri 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.

Melinda Magyari (M)

Department of Neurology, Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, 2100, Copenhagen, Denmark.

Hanna Joensen (H)

The Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Luigi Pontieri (L)

The Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Frederik Elberling (F)

The Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Pernilla Klyve (P)

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

Elena Flavia Mouresan (EF)

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

Lars Forsberg (L)

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

Jan Hillert (J)

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden. jan.hillert@ki.se.
ORCID: 0000-0002-7386-6732

Classifications MeSH