As we close out 2024, we are proud to reflect on the significant progress we have made over the past year with the RECLAIM study. We now have longitudinal data from over 900 patients, including more than 13,000 MRI scans, all of which have been quantitatively analysed.
RECLAIM (NCT06280755) aims to improve the care and understanding of Multiple Sclerosis (MS) patients by reusing real-world clinical data in combination with clinical trial data. This data is used to develop AI-powered models that can predict certain aspects of MS disease progression and worsening, aiding clinicians in making more informed treatment decisions. Additionally, this unique dataset will generate new insights into disease progression and contribute to the development of tools to better monitor this progression.
In the first half of the year, we focused on establishing all key documents for the study and obtaining the necessary signatures and approvals. We established the study protocol, the data processing agreement, the data protection impact assessment, informed consent forms, obtained Ethics Committee (EC) approvals, etc … . These foundational documents have been reviewed by clinical, ethical, and technical experts to ensure compliance with ethical and data privacy and security standards, as well as the latest industry standards, enabling us to move forward with confidence.
In the second half of the year, we initiated the data transfers and analyses. To date, we have over 900 MS patients in the study, and this number is growing rapidly. Many of these patients were followed up longitudinally, with some sharing over two decades of data. MRI data was collected from all of these patients, amounting to well over 13,000 MRI scans to date, all of which have been quantitatively analysed. An initial positive test of centrally analysing OCT scans was performed, and, last but not least, for four of the data partners, we have set up the data mapping rules for their clinical data, allowing these results to be integrated into our harmonised database.
The last key milestone which we want to highlight was the successful implementation of the technical process of pseudonymising different data modalities, transferring them to a central storage location, analysing the various imaging modalities, and then linking all of a patient’s data back together and mapping this data and results to our MS-specific Common Data Model. Development of this common data model was a collaborative effort with all CLAIMS partners, and more details will soon be shared via a publication we are preparing.
As we move into 2025, the momentum behind the RECLAIM study continues to build. With the support of the CLAIMS partners and the growing dataset, we are excited to continue transforming how we understand, monitor, and treat Multiple Sclerosis.
