People with Multiple Sclerosis (MS) have the right to access optimal care for their individual needs in a timely matter.
The MSDA initiative originated from the advocacy work for better use of real-world data (RWD) performed by the European Multiple Sclerosis Platform (EMSP). EMSP is a Pan-European umbrella of MS societies which represents those living with MS in Europe and has a network of member societies in 34 European countries. RWD is defined as data derived from a number of sources that are associated with outcomes in a heterogeneous patient population representing the real-world settings (e.g. data collected by physicians in standard clinical care and longitudinal follow-up). High quality RWD is required for many different purposes. For example: 1° regulators need data for life-cycle assessment of medicinal products from basic research to the evaluation of their effectiveness and safety in clinical practice; 2° health technology assessment bodies want to incorporate data from clinical practice into the drug development process, 3° RWD is used increasingly to address clinical questions related to MS disease behavior, prognosis and treatment. Despite the increasing reliance on RWD, challenges and limitations exist that complicate the collection, and use of this data.
The European Register for Multiple Sclerosis (EUReMS) has proved that cross-border MS data collection is possible and addressed the lack of data at EU and national level on treatment and care for people with MS. The project ran between 2011 and 2014 under the coordination of a consortium of academic institutions and non-governmental organizations. In 2015, the European Medicine Agency (EMA) launched its Patient Registries Initiative, aiming to optimize and facilitate the use of existing patient registries for the benefit-risk monitoring of medicinal products throughout their lifecycles. In 2017, this EMA Patient Registry initiative selected MS as one of their pilot projects and an MS-specific workshop was organized in 2017. This workshop aimed to come to agreements of factors that will help to ensuring the quality of interoperability of MS registry data for supporting regulatory evaluations while ensuring also that appropriate governance arrangements are in place. The report of this meeting was one of the major inspirations for the discussions of the first MSDA working group brought together by EMSP in 2017. Several brainstorm sessions of the working group during 2018 resulted in a concrete kick-off year in 2019. At that time, the MSDA initiative was a joint initiative of Hasselt University (UHasselt, Belgium) and EMSP.