CTTI’s Embedding Trials Feasibility Tool Launch

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.

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants – A Randomized Clinical Trial

Posted on May 31, 2022December 18, 2023 by kristi.geercken@duke.edu

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants – A Randomized Clinical Trial

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.