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.

Center for Outcomes Research and Clinical Epidemiology CORESEARCH Pescara Italy

Department of Clinical Neuroscience Karolinska Institute Stockholm Sweden

Department of Life Sciences University of Siena Siena Italy

Department of Neurology and Center of Clinical Neuroscience 1st Faculty of Medicine Charles University and General University Hospital Prague Prague Czech Republic

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

Department of Neurology The Alfred Hospital Melbourne VIC Australia

Department of Neuroscience Central Clinical School Monash University Melbourne VIC Australia

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

Eugène Devic EDMUS Foundation Against Multiple Sclerosis State Approved Foundation 69677 Bron France

IMPULS Endowment Fund Prague Czech Republic

INSERM 1028 et CNRS UMR 5292 Observatoire Français de la Sclérose en Plaques Centre de Recherche en Neurosciences de Lyon 69003 Lyon France

Research Department Italian Multiple Sclerosis Foundation Genoa Italy

School of Medicine University Aldo Moro Bari Italy

Service de Neurologie sclérose en plaques pathologies de la myéline et neuro inflammation Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer 69677 Bron France

South Eastern Health and Social Care Trust Belfast UK

The Danish Multiple Sclerosis Registry Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

Université de Lyon Université Claude Bernard Lyon 1 69000 Lyon France

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