Expert Meeting on Large Simple Trials (LSTs)

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 Presentations:

Day 1 - Session 1: Landscape of LSTs

Day 1 - Session 2: Models of Approaches to LSTs 

Day 2

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.

Improving Human Health through Large Simple Trials

“Randomized clinical trials remain the most reliable means of identifying the drugs, devices, and treatment strategies that will improve human health.”
– 
Zubin J. Eapen, MD, MHS, Michael S. Lauer, MD, and Robert J. Temple, MD

On May 13-14, 2013, CTTI hosted an expert meeting on the need to streamline the conduct of large simple trials (LSTs) in the U.S. This meeting convened a broad array of engaged stakeholders including regulators, government sponsors of clinical research, members of academia and industry, patient advocates, clinical investigators, and other interested parties. The primary objective of this meeting included discussing the following:

  • Findings from a survey of practices
  • Strategies that companies are using to implement LSTs
  • The challenges to LSTs

The summary of this expert meeting is now available on the CTTI website.

Additionally, the key takeaways from this expert meeting were captured in a recent JAMA Viewpoint publication, The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials. Co-authored by three of CTTI’s LST Project Team Members (Zubin J. Eapen, MD, MHS, Michael S. Lauer, MD, and Robert J. Temple, MD), this perspective piece highlights how the U.S. healthcare system stands to benefit from larger, simpler, less expensive randomized trials. This article also touches on the possibility of leveraging existing data collection platforms to enhance patient enrollment in LSTs, as well as the ability of funding opportunities to encourage streamlined trial design.

The authors concluded, “With the current opportunities to streamline trials and leverage existing clinical data, conducting large, simple trials is more possible than ever and presents a path forward for advancing human health.”

For more information about CTTI’s LST Project, CLICK HERE.