MAY 13, 2013 TO MAY 14, 2013

CTTI Project: Large Simple Trials

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 Location:

Hilton Washington DC/Rockville Hotel and Executive Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

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