JANUARY 21, 2015 TO JANUARY 22, 2015

CTTI Project: Patient Group Engagement

Meeting Objectives

• 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 3-way 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

Meeting Location:

Fairmont Hotel, Washington, DC

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

DAY 1 – JANUARY 21 , 2015

• Welcoming Remarks and Overview Dr. by Pamela Tenaerts and Bray Patrick-Lake
• Success from Start to Finish: Multi-Stakeholder Engagement by William Tunno
• Key Findings from CTTI’s Project on Best Practices for Effective Engagement with Patient Groups around Clinical Trials by Wendy Selig
• The Learning Collaborative | A Unique Government - Disease Philanthropy - Academia Collaboration by Dr. Scott Weir and Dr. G. Sitta Sittampalam
• Therapy Acceleration Program® (TAP): filling a “gap” in our research programs by Jun Xu
• FARA Example of Public-Private Partnership by Ron Bartek
• Opportunities for Engagement by Joel Beetsch
• Regulatory Restrictions on “Promotion” of Investigational Products by Carla Cartwright
• Understanding Clinical Trial Recruitment Rules: Debunking Myths by Richard Klein
• Conflicts of Interest – Real and Apparent Issues by Ron Bartek
• Navigating the Rules of Engagement: In-house counsel perspective by Rebecca Prince
• Breakout Session 2 Framework

DAY 2 – JANUARY 22 , 2015

• The Cost of Clinical Trial Delays by Ken Getz
• What Industry is Measuring Around Patient Group Partnerships by David Leventhal
• Impact of Patient Engagement on Project Valuation by Dr. Bennett Levitan
• Progress Through Partnership: Integrating Stakeholders into the Clinical Research Process by Dr. Petra Kaufmann