[DIA Europe 22] Early Patient Engagement in Drug Development & Decision Making

Integrating patient voice in medicine development and decision-making has introduced more quantitative approaches to generating patient input and evidence. IMI PREFER has been instrumental in developing the approach to gathering patient preferences, and work has been ongoing globally to develop more patient-relevant clinical outcomes. FDA and ICH work on patient-focused medicines development, and more guidance is expected in the coming years. Even if it is acknowledged that patients are central to development programs and regulatory decision-making, there remain challenges to implementing the systematic evidence generation and subsequent use of this evidence in benefit-risk assessment, as well as securing patient involvement as early as possible for this purpose. During our DIA Europe's last edition, we brought together patients, regulators, and researchers from public and private sectors to discuss lessons learned from the specific example of interactions on patient-generated evidence, practical solutions found and how these can help progressing patient engagement in other parts of the R&D and medicines evaluation processes: Challenges encountered by Industry when developing the evidence and interacting with the regulators to engage with patients and include patient preferences and patient-centric outcomes in the product information. The Regulators’ perspective on progress and experience using patient evidence for benefit-risk decision-making. The Patient perspective on the issues, proposed solutions, and their impact on patient groups.