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W-21: Effective Engagement Between Sponsors & Patient Groups: A Structured Process and Use Cases from CTTI

Poster Presenter

      Zachary Hallinan

      • Senior Project Manager
      • Clinical Trials Transformation Initiative (CTTI)
        United States


Develop a structured process for identifying engagement opportunities with high value for both sponsors and patient groups.


Semi-structured interviews were conducted with representatives from a range of sponsor companies (n=14) and patient groups (n=14) to understand factors considered when evaluating the benefits and investments required for sponsor/patient-group engagement.


Building on existing work—including multi-stakeholder recommendations for effective engagement and approaches to demonstrating the financial return on investment of patient group engagement—the Clinical Trials Transformation Initiative (CTTI) has conducted new research with sponsors and patient groups, and developed a structured process for quickly identifying engagement opportunities with high value for both parties. The poster will summarize this evidence-based process, as well as findings from the interviews and insights on factors that drive value for stakeholders.


As a new generation of sophisticated patient groups has begun to seek meaningful involvement across the drug development process, biopharmaceutical companies have increasingly identified opportunities to weave the patient voice into the fabric of the clinical research enterprise. However, while there is now widespread recognition of the importance of engagement between sponsors and patient groups, additional guidance and tools are needed to support engagement that is both meaningful and effective. This work provides such a tool.