One of the main objectives of the ‘Multiple Sclerosis Data Alliance’ (MSDA) is 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. Improving the collection and analysis of real-world evidence can lead to better informed policy and decision makers, regulators, patients and better research outcomes.
MSDA aims to influence a mind-shift on the vital importance and multifaceted usability of good-quality real world data - urgently needed as additional evidence for proper decision making by health authorities. It is designed to boost research and enable better outcomes for the broader MS community with a focus on Patient Reported and Patient Relevant Outcomes (PRO).
During 2019, MS Data Alliance went online and developed the topics for promoting trustworthy and transparent practices in the way Real World Evidence (RWE) is used. In this respect, several educational sessions helped the MS community to have a better understanding of these subjects.
The recruitment of registries was ongoing throughout the year. As a result of which, 4 new registries have accepted to take part in the MSDA initiative. The meta-data of 10 registries is now available and a minimal data set has been defined and is being tested for 2 pioneering registries.On 20 November 2019, a Stakeholder Engagement Meeting was held in Baveno, Italy, gathering 100 stakeholders. These included the MS community represented by individual people with MS, MS Societies, researchers, clinicians, data custodians, industry representatives and regulatory decision makers. Besides raising awareness about the importance of research using real-world MS data, coming together in Baveno helped the MSDA to lay down its organisational foundations for the next years to come.