CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.
CLICK HERE for the meeting summary.

Meeting Background

The purpose of this meeting is to develop recommendations to facilitate and promote the adoption of LST designs for regulatory submissions or other purposes.

Meeting Objectives

• Discuss findings from a survey of practices 
• Discuss strategies that companies are using to implement LSTs 
• Discuss the challenges to LSTs

Meeting Presentations*

• 1.1 Welcome by Leanne Madre
• 1.2 Opening Remarks by Christopher Granger

Day 1 - Session 1: Landscape of LSTs

• 1.3 Perspectives on LST Trials by Michael Lauer
• 1.4 Patient Perspective on LST Trials by Carolyn Petersen
• 1.5 Opportunities for LSTs - Industry by Reshma Kewalramani
• 1.6 Opportunities for LSTs - Regulatory Sandra Kweder
• 1.7 Summary of Survey Results by Patrick Archdeacon

Day 1 - Session 2: Models of Approaches to LSTs 

• 2.1 Models of Industry Trials for Regulatory Purpose (Efficacy/Effectiveness) by Christopher Granger
• 2.2 Models of Industry Trial for Regulatory Purposes (Safety) by Frank Cerasoli
• 2.3 Pragmatic Trials using EHR Platforms by Ryan Ferguson
• 2.4 Population-based trials with high cost-efficiency (VITAL) by JoAnn Manson
• 2.5 CHAMPION Program by Meredith Todd
• 2.6 CHAMPION Program – FDA Perspective by Stephen Grant
• 2.7 SHARP by Colin Baigent
• 2.8 JUPITER by Johannes Hulthe
• 2.9 SHARP and JUPITER - FDA Perspective by James Smith

Day 2

• 3.1 Summary of Day 1, including review of challenges to increased adoption of LST trial designs and potential solutions by Christopher Granger
• 3.2 Reflections on Challenges and Potential Solutions by Robert Temple

*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.