April 4, 2023
CTTI Project: Engaging All Stakeholders in Clinical Trial Design
Meeting Objectives:
- Review two clinical trial ‘models’ where stakeholder engagement was well-executed
- Discuss and explore opportunities, barriers, and best practices for study designers to engage all stakeholders in trial design
- Identify situation-specific considerations for ensuring engagement is appropriately equitable, effective, and feasible
Meeting Location: Washington, D.C.
Meeting Materials:
- Welcome Remarks and Opening Comments
- Introduction to the Clinical Trials Transformation Initiative (CTTI)
- Engaging Stakeholders in Trial Design Project Overview
- Meeting Objectives
- Session 1: Models for Success
- Review of two well-executed trials
- Key milestones and interactions that supported success
- Discussion: What does a well-engaged trial look like?
- Methods and milestones
- Roadblocks to engagement
- Session 2: Challenges and Opportunities
- Panel discussion: opportunities, barriers, and best practices for engaging all stakeholders in trial design
- Building the value proposition of engaging stakeholders in trial design
- Timing of stakeholder engagement
- Operationalizing stakeholder feedback
- Simplifying the process
- Measuring the impact
- Panel discussion: opportunities, barriers, and best practices for engaging all stakeholders in trial design
- Session 3: Break Out Sessions
- Timing of stakeholder engagement
- Simplifying the stakeholder engagement process
- Measuring the impact of stakeholder engagement in the design of clinical trials
The views and opinions expressed in these presentations 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.