Patient Relevant Osteoarthritis endpoints using Big data Evaluation

Objective

Osteoarthritis (OA) causes pain, disability, and economic burden for 500+ million people. Developing disease modifying osteoarthritis drugs is crucial, but challenging due to disease heterogeneity, slow progression, and regulatory issues. The PROBE consortium addresses these challenges by integrating diverse and disparate datasets, combined with all necessary expertise, creating a federated database network. PROBE will unite critical mass in OA data and multidisciplinary disease specific expertise, federated infrastructure experts, AI and ML expertise, data privacy and ethics experts, health economics and outcome researchers, and indispensable patient, HTA, and regulatory perspectives experts, to achieve significant advancements in trial designs and tools for shared decision making. The overarching aim of PROBE is to deliver data-driven opportunities for the treatment of OA, through enhancements in patient stratification, predicative modelling, patient/caregiver interface decision tools and clinical trial design. Outcomes include a federated and regulatory compliant database network of disparate OA data for powerful, innovative big data methodology. In close collaboration with key stakeholders, we will also provide novel multimodal and relevant endpoints to test emerging treatments, models to enable stratified medicine and support shared prognostic and treatment decision-making and Health Technology Assessment. The impact of PROBE encompasses the foundation for advanced clinical trial design, predictive models for OA progression, novel endpoints, stratified patient subgroups and the ability to target treatments to patients’ needs and preferences, and tools that enable specific functional measurements and reflect real-life treatment benefits. The PROBE consortium holds the potential to reshape the landscape of OA clinical trials/treatment and ultimately improve the lives of all people affected by OA.