(C-173) Framework for Integrating Physician Stakeholder Feedback into Real-world Data Studies

Background: Several published frameworks have emphasized the importance of effective stakeholder engagement in real-world data (RWD)-based research programs. While most guidelines focus on patient engagement, physicians can play an equally vital role in generating and interpreting data, ensuring the research is fit-for-purpose at the point of care. Recognizing their crucial role, there is a growing interest in systematically incorporating physician stakeholder feedback into RWD-based research.

Objectives: To develop a comprehensive operational and scientific framework for integrating physician stakeholder feedback into RWD studies.

Methods: A literature review was conducted to identify existing frameworks and best practices for stakeholder engagement. Their applicability to engaging physicians was evaluated through discussions with subject-matter experts. Subsequently, a framework was designed to systematically integrate clinical stakeholder feedback into RWD, addressing both operational and scientific considerations.

Results: We identified three study design approaches that integrate physician feedback into traditional RWR studies, including 1) utilizing qualitative clinician insights to interpret quantitative RWD findings, 2) engaging clinicians to establish priorities for a RWD study, and 3) creating an iterative feedback loop between quantitative RWD and qualitative clinician insight. A decision-making tool was used to operationalize physician engagement, addressing aspects such as setting (i.e., focus group, 1:1 interviews, surveys), participant selection criteria (i.e., geography, experience, expertise), choice of moderator (i.e., physician peer or researcher, internal or external to study team), and considerations for incorporating pre-reading materials. The tool was applied to a series of RWD oncology use cases, including outcomes modelling, treatment pattern, and testing pattern studies.

Conclusions: Careful integration of physician stakeholder feedback into the design and interpretation of RWD studies can yield valuable scientific and operational advantages, including maximizing the clinical utility of these studies and supporting increased adoption of real-world evidence by physicians for clinical decision-making. We created an innovative framework to facilitate this integration, thereby enhancing the translational potential of RWD-based studies.