PCN518 ONCOLOGY REAL WORLD DATA (RWD): ENABLING LEARNING HEALTH SYSTEMS

Abstract

Unprecedented advances in oncology innovation and precision medicine are increasing treatment complexity. Sharing Real-World Data (RWD) on routine practice systematically is critical to help navigate this. This abstract aims to describe how this goal can be realized. It draws lessons from a collaborative European data-sharing platform developed to inform best practice, highlight variations in care, catalyze research and help address financial sustainability challenges. Through a collaborative approach with patients, clinicians, biopharmaceutical companies and cancer organizations, IQVIA, supported by the Collaboration for Oncology Data in Europe (CODE), assessed the infrastructural and data requirements of a data-sharing platform to meet oncology stakeholders’ needs. Data protection authorities were consulted to understand data processing and warehouse requirements. Methodologies to address all requirements were then identified. Pre-requisites identified included: low latency data access, comparability, sufficient clinical depth, support and involvement of, and minimal administrative burden to the clinical community, GDPR alignment, and flexibility to facilitate different payment models. The Oncology Data Network (ODN) was constructed using ‘data protection by design,’ aligning with the EU GDPR. The ODN will provide analytically ready data in <24 hours on a concise set of variables including clinical & demographic characteristics, biomarkers, indication of use, and detailed drug utilization including treatment plan, dispensing and administration for all anti-cancer medicines longitudinally in a patients’ medical pathway across settings of care. 115 European sites in 6 countries have joined, representing approximately 80,000 patients receiving anti-cancer therapy. The mapping of 28,000 distinct anti-cancer regimens enables comparability. RWD from the ODN will enable us to generate timely insights and assess utilization of anti-cancer medicines, prescribing patterns, adherence to guidelines, bench marking data across countries, and potentially develop innovative agreements to ultimately improve access for patients.