Innovative Trials

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

Meeting Materials:

Watch Public Summit

Presentation Slides

Survey Results Slides

Articles of Interest

Master Protocol COVID Treatment Resources

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.

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 Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

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.

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

Meeting Materials:

Meeting Agenda

Meeting Summary

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Decentralized Clinical Trials Update Expert Meeting

AUGUST 25, 2021 TO AUGUST 26, 2021

CTTI Project: Supporting Decentralized Trial Approaches

Meeting Objectives:

In order to update CTTI’s existing decentralized clinical trials (DCT)* recommendations, this expert meeting aimed to:

  • Collect recent knowledge and insights – both what works and what doesn’t – from operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping)
  • Understand current practices for incorporating DCT solutions in clinical trials, including considerations for protocol design and safety monitoring
  • Identify opportunities to increase adoption of DCT solutions moving forward

*For the purposes of this meeting, DCTs were defined as those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).

Meeting Location:

Virtual Meeting

Meeting Agenda

Meeting Summary

List of Meeting Attendees

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Pre-Meeting Landscape Scan Results

Meeting Materials:

Day 1

Day 2

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.

Embedding Trials in Clinical Practice Expert Meetings

May 11, 2022 & September 21, 2022 

CTTI Project: Trials in Clinical Practice

MEETING OBJECTIVES: 

Meeting #1 Objectives:

  • Present findings from project’s evidence generation: in-depth interviews with study designers and implementers
  • Refine operational recommendations
  • Begin to strategize implementation of the operational recommendations

Meeting #2 Objectives: 

  • Develop strategies for implementing at least 2 of CTTI’s new recommendations into the planning of trials intended for regulatory review
  • Identify 3 implementation barriers that trial designers and health systems have the power to mitigate
  • Brainstorm relevant metrics to monitor and evaluate implementation of the selected recommendations

Meeting #1 Location: Virtual Meeting

Meeting Agenda

Meeting Summary

List of meeting attendees

Full Presentation Set

Meeting #1 Materials:

  • Session 1: Introduction to Embedding Trials in Health Care Settings 
    • Introduction to the Clinical Trails Transformation Initiative (CTTI) 
    • Trials in Health Care Settings Project Overview and Meeting Objectives 
    • Review of Project’s In-depth Interview Results 
  • Session 2: Leveraging Examples to Refine Recommendations 
    • Review of Project’s Draft Recommendations 
    • Case Examples 
  • Session 3: Strategizing Implementation of Recommendations 
    • Opportunities to Implement CTTI Recommendations 

Meeting #2 Location: Hotel Washington, 515 15th Street, NW Washington, D.C.

Meeting Agenda

Meeting Summary

List of meeting attendees

Full Presentation Set

Meeting #2 Materials:

  • Session 1: Paving the Way 
    • Integrating Clinical Research and Care: Perspectives from Groups Paving the Way 
    • TQ&A 
    • Trials in Clinical Practice Project Overview  
  • Session 2: Implementation Workshop 
  • Session 3: Developing Metrics of Implementation 
    • Level setting on what is meant by metrics and implementation 
    • Metrics Development: Breakout Groups 
    • Gaining Momentum 

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.

Recent Webinars

New Resources for Designing and Running Master Protocols

CTTI Project: Master Protocol Studies

 

Webinar Presenters:

  • Abby Bronson, Edgewise Therapeutics
  • Marianne Chase, Massachusetts General Hospital
  • Daniel Millar, Janssen R&D
  • Nick Richardson, FDA, CDER

Webinar Resources:

PDF iconDownload Slides

Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database

CTTI Project: Electronic Healthcare Data

PDF icon Download Slides

Webinar Presenters:

  • Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
  • Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University

Webinar Objective:

This webinar provides an update on the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.

Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This webinar discusses the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.

IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.