Patient-Centered Real-World Evidence Framework for Oncology Product Development

As use of real-world evidence (RWE) in oncology continues to increase, guidance is needed to ensure the patient voice is captured when generating RWE. This paper proposes a practical methodological framework for patient-centered RWE (PCRWE) throughout oncology product development. The need for a novel framework was first established by a review of existing literature and RWE guidelines. This review indicated an unmet need for a clear definition of PCRWE and a framework to guide PCRWE research in oncology. We define PCRWE as RWE that incorporates patient-centered objectives, provides insights into patient-relevant questions, and may lead to assessments of the usage, benefits, or risks of a medical treatment reflecting the patient perspective. The review's findings were used to create a preliminary PCRWE framework, which was finalized following interviews with RWE stakeholders and oncologists. The final PCRWE framework, which is grounded in the existing regulatory and scientific landscape, is an interactive visual tool for generating, implementing, and disseminating PCRWE in oncology. It accommodates various levels of expertise among users and supports the alignment of terminology to describe PCRWE. The framework will enable stakeholders to identify unmet needs from the patient perspective and to more effectively demonstrate the value of new oncology products.