Key stakeholders in the clinical trials enterprise have declared a commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, leading to better clinical trials; however, no guidelines for best practices currently exist. Actionable recommendations are needed, and CTTI is working to address this unmet need.
On January 21-22, 2015, CTTI convened a multi-stakeholder group of experts and thought leaders from across the clinical trials enterprise to address barriers to patient group engagement. Specifically, the meeting attendees set out to:
- Define consensus principles of Patient Group engagement from the 3-way (Industry, Patient Group, and Academia) stakeholder perspectives using case studies of success and barriers
- Share evidence and key findings from a multi-stakeholder assessment of Patient Group engagement in the Clinical Trial process
- Gain understanding of the FDA Rules of Engagement and various Conflict of Interest (COI) issues
- Solicit feedback on evidence to inform recommendations that can further enhance the value to industry, academia and patient groups of mutually beneficial partnerships that engage the patient groups as fully as possible in the complete spectrum of the clinical research enterprise
- Solicit feedback on benchmarking, metrics, and value of patient engagement in clinical trials for research sponsors
In addition to providing the presentation materials from this expert meeting, we are pleased to share the summary as well. These materials describe the current landscape of patient engagement, and provide an evidence-based foundation for moving forward.