Contributions
Abstract: EP1641
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
The ultimate goal of the MS Data Alliance (MSDA) is improved care for people with Multiple Sclerosis (MS). We believe a crucial step towards this goal is to invest in “better data for better decision-making”. Two key priorities are formulated: 1° The implementation of a minimal data set and quality standards, approved by the European Medicine Agency (EMA), in as many MS data registries and cohorts as possible. 2° The existence of a federated IT independent data ecosystem that supports re-use and request-based pooling of data when necessary and tackles the challenges of data sharing.
Real-World Data (RWD) can provide longitudinal information on the effectiveness and tolerability of drugs, their impact on resource use, medical costs, and patient-reported outcome (PRO). This is particularly important in MS, where economic treatment benefits of long-term disability reduction are a cornerstone of drug approvals by the payer. These factors are typically not examined in RCTs themselves but modelled using RWD. A growing number of MS databases and registries have started to produce long-term outcome data from large cohorts of patients with MS treated with disease-modifying therapies in real-world settings. However, collaborative initiatives face many challenges, because access to MS registries and/or cohorts is limited and data discovery is time consuming. Data is acquired heterogeneously and differences in definitions, indexing and software platforms preclude direct integration.
Three objectives are formulated for this project proposal: 1° Facilitate community engagement and raise awareness on the value of quality RWD. We do this by launching a multi-facetted awareness and motivation campaign and by organizing large scale engagement meetings for a wide group of stakeholders; 2° Develop tools for data discovery and sharing in collaboration with experts in data sharing (e.g. ELIXIR, Observational Health Data Sciences and Informatics (OHDSI), European Medical Information Framework (EMIF), European Health Data Networks (EHDEN), Big Data for Better Outcomes (BD4BO),
). 3° Support implementation strategies and standard operating procedures for a wide international implementation of a minimal data set including PRO and MRI measures.
We believe a collaborative and synergistic approach is required to jointly tackle these challenges. We are currently in the process of finalizing the project consortium and implement our raising strategy to make this vital project happen.
Disclosure: Liesbet M. Peeters: nothing to disclose
Tina Meissner: nothing to disclose
Alexander Stahman: has nothing to disclose
Rod Middleton: nothing to disclose
Christoph Thalheim, in his capacity as consultant for EU health affairs, has received consultancy fees by Gruenenthal and by PharmaGenesis. In his capacity as Director External Affairs of the European MS Platform, he served in advisory boards and/or workshops by Biogen, Merck, Novartis, Sanofi Genzyme, Servier and Takeda. His employer, the European MS Platform, has received unrestricted project grants from Actelion, Almirall, Bayer, Biogen, icometrix, MedDay, Merck, Mylan, Novartis, Roche, Sanofi Genzyme, SCA, Servier, Synthon, Terumo and Teva.
Abstract: EP1641
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
The ultimate goal of the MS Data Alliance (MSDA) is improved care for people with Multiple Sclerosis (MS). We believe a crucial step towards this goal is to invest in “better data for better decision-making”. Two key priorities are formulated: 1° The implementation of a minimal data set and quality standards, approved by the European Medicine Agency (EMA), in as many MS data registries and cohorts as possible. 2° The existence of a federated IT independent data ecosystem that supports re-use and request-based pooling of data when necessary and tackles the challenges of data sharing.
Real-World Data (RWD) can provide longitudinal information on the effectiveness and tolerability of drugs, their impact on resource use, medical costs, and patient-reported outcome (PRO). This is particularly important in MS, where economic treatment benefits of long-term disability reduction are a cornerstone of drug approvals by the payer. These factors are typically not examined in RCTs themselves but modelled using RWD. A growing number of MS databases and registries have started to produce long-term outcome data from large cohorts of patients with MS treated with disease-modifying therapies in real-world settings. However, collaborative initiatives face many challenges, because access to MS registries and/or cohorts is limited and data discovery is time consuming. Data is acquired heterogeneously and differences in definitions, indexing and software platforms preclude direct integration.
Three objectives are formulated for this project proposal: 1° Facilitate community engagement and raise awareness on the value of quality RWD. We do this by launching a multi-facetted awareness and motivation campaign and by organizing large scale engagement meetings for a wide group of stakeholders; 2° Develop tools for data discovery and sharing in collaboration with experts in data sharing (e.g. ELIXIR, Observational Health Data Sciences and Informatics (OHDSI), European Medical Information Framework (EMIF), European Health Data Networks (EHDEN), Big Data for Better Outcomes (BD4BO),
). 3° Support implementation strategies and standard operating procedures for a wide international implementation of a minimal data set including PRO and MRI measures.
We believe a collaborative and synergistic approach is required to jointly tackle these challenges. We are currently in the process of finalizing the project consortium and implement our raising strategy to make this vital project happen.
Disclosure: Liesbet M. Peeters: nothing to disclose
Tina Meissner: nothing to disclose
Alexander Stahman: has nothing to disclose
Rod Middleton: nothing to disclose
Christoph Thalheim, in his capacity as consultant for EU health affairs, has received consultancy fees by Gruenenthal and by PharmaGenesis. In his capacity as Director External Affairs of the European MS Platform, he served in advisory boards and/or workshops by Biogen, Merck, Novartis, Sanofi Genzyme, Servier and Takeda. His employer, the European MS Platform, has received unrestricted project grants from Actelion, Almirall, Bayer, Biogen, icometrix, MedDay, Merck, Mylan, Novartis, Roche, Sanofi Genzyme, SCA, Servier, Synthon, Terumo and Teva.