The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies

JANUARY 13, 2021

CTTI Project: Clinical Trial Issues Related to COVID-19

Meeting Overview:

CTTI hosted The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit on Wed., Jan. 13. The summit, conducted as a webinar and moderated by Pamela Tenaerts, CTTI, included a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and panel discussions moderated by Ester Krofah, FasterCures, and Mark McClellan, Duke-Margolis Center for Health Policy. The panel focused on solutions related to scaling master protocols, including:

  • Overcoming barriers to starting up sites
  • Increasing participants at existing sites
  • Using the COVID experience to inform our preparedness for future pandemics

The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and findings of a pre-summit survey that offered best practices and insights from those involved in COVID-19 treatment master protocols, specifically those setting up new sites and recruiting participants at existing sites.

This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.

Meeting Location:

Virtual Meeting

Meeting Agenda

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.

Master Protocol 2019 Expert Meeting

OCTOBER 22, 2019 TO OCTOBER 23, 2019

CTTI Project: Master Protocol Studies

Meeting Overview:
The purpose of the meeting was to explore and develop strategies to address common challenges related to the design and implementation of master protocols, including:

  • Mapping the pre-planning, planning, and execution processes of a master protocol trial.
  • Strategizing solutions to common roadblocks related to the pre-planning, planning, and execution of a master protocol study.
  • Identifying and prioritizing the creation of tools to support the adoption of emerging best practices outlined by CTTI’s roadmap.

Meeting Materials:

Meeting Agenda

Meeting Summary

Roadmap

Participant List

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Welcoming Remarks & Meeting Overview

Session I: Landscape Review

Session II: Building Capacity for Innovation

Session III: Small Group Breakout Sessions

Session IV: Tool Identification

Session V: Next Steps & Closing Comments

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.

Master Protocol 2020 Expert Meeting

APRIL 20, 2020 TO APRIL 21, 2020

CTTI Project: Master Protocol Studies

Meeting Overview:
The purpose of the meeting was to continue to drive the development of publicly available resources to support the successful design and implementation of master protocol studies. Specific meeting objectives included the following:

  • Refine CTTI tools to support the development of emerging master protocol studies in diverse therapeutic areas
  • Identify specific capacity building efforts to support cross-institutional collaboration in response to COVID-19 and other major public health threats