Article from Assoc. Prof. Anna Glaser from Karolinska Institutet, Sweden, focuses on the importance and contribution of European multiple sclerosis registries, specifically the Big Multiple Sclerosis Data Network (BMSD) project, in which ReMuS is actively involved. In it, readers will find an overview of what data is being collected across Europe and how this data is helping not only scientists but also physicians to improve patient care.
Glaser, A., Butzkueven, H., van der Walt, A., Gray, O., Spelman, T., Zhu, C., Trojano, M., Iaffaldano, P., Battaglia, M. A., Lucisano, G., Vukusic, S., Vukusic, I., Casey, R., Horakova, D., Drahota, J., Magyari, M., Joensen, H., Pontieri, L., Elberling, F., Klyve, P., Mouresan, E.F., Forsberg, L., Hillert, J. (2024). Big Multiple Sclerosis Data network: an international registry research network. And Journal of Neurology (Vol. 271, Issue 6, pp. 3616-3624). Springer Science and Business Media LLC. https://doi.org/10.1007/s00415-024-12303-6 PMID: 38561543
Abstract
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.
Entire paper is available in English on the website of the Journal of Neurology.
