OCTOBER 22, 2019 TO OCTOBER 23, 2019
CTTI Project: Master Protocol Studies
Meeting Overview:
The purpose of the meeting was to explore and develop strategies to address common challenges related to the design and implementation of master protocols, including:
- Mapping the pre-planning, planning, and execution processes of a master protocol trial.
- Strategizing solutions to common roadblocks related to the pre-planning, planning, and execution of a master protocol study.
- Identifying and prioritizing the creation of tools to support the adoption of emerging best practices outlined by CTTI’s roadmap.
Meeting Materials:
Welcoming Remarks & Meeting Overview
- Introduction to the Clinical Trials Transformation Initiative (CTTI) - Annemarie Forrest, CTTI
- VeloCTTI Master Protocol Project Overview - Kimberly Fisher, CTTI
Session I: Landscape Review
- Landscape Review Findings - Nicholas Richardson, FDA, CDER
- Multi-Stakeholder, Cross-Institutional Strategies for Change - Daniel Millar, Janssen Pharmaceuticals
- Leveraging Master Protocols to Build Local Infrastructure & Technical Capacity for Low & Middle-Income Countries - Jay Park, MTEK Sciences
Session II: Building Capacity for Innovation
- I-ACT for Children Overview - Ed Connor, I-ACT for Children
- xCures Overview - Mika Newton, xCures
Session III: Small Group Breakout Sessions
- Pre-Planning - Jane Perlmutter & Annemarie Forrest, CTTI
- Planning - Marianne Chase, Massachusetts General Hospital & Kimberly Fisher, CTTI
- Execution - Roger J. Lewis, Berry Consultants, LLC & Laura Shannon, CTTI
- Large Group Discussion
Session IV: Tool Identification
- Roadmap Strategy Session Instructions - Kimberly Fisher, CTTI
- Breakout Session Facilitators
- Pre-Planning - Karen Dimick, Genentech & Annemarie Forrest
- CTTI Planning - Gene Vinson, Syneos Health & Kimberly Fisher
- CTTI Execution - Rajeshwari Sridhara, FDA, CDER, & Laura Shannon, CTTI
- Large Group Strategy Session - Facilitator/Moderator: Nicholas Richardson, FDA, CDER
Session V: Next Steps & Closing Comments
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.