Diversity Maturity Model for Organizational-Level Strategies
Study Design
Engaging Stakeholders in Trial Design Expert Meeting
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.
Disease Progression Modeling Expert Meeting
March 6, 2023
CTTI Project: Using Disease Progression Modeling to Advance Trial Design and Decision Making
MEETING OBJECTIVES:
- Discuss disease progression modeling (DPM) and its current applications
- Explore opportunities, barriers, and best practices for advancing the use of disease progression modeling to aid in decision making
- Brainstorm relevant metrics to monitor and evaluate the recognition, value and consistent use of disease progression modeling
Meeting Location: Mayflower Hotel, Washington, D.C.
Meeting Materials:
- Session I: Project Overview
- Session II: Challenges and Solutions for DPM Advancement
- Session III: Facilitating Progress
- Recommendations & Resources: Open Discussion
- Metrics to Measure Change
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.