COVID 19

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.

Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic

CTTI Project: Clinical Trials Issues Related to COVID-19

 

Webinar Presenters:

  • David Borasky (WIRB-Copernicus Group)
  • Sara Calvert (Clinical Trials Transformation Initiative)
  • M. Khair ElZarrad (Food and Drug Administration/CDER)
  • Cindy Geoghegan (Individual Patient Representative/Caregiver)
  • Colleen Rouse (Cleveland Clinic)
  • Pamela Tenaerts (Clinical Trials Transformation Initiative)

PDF icon Download Slides

 

 

CTTI Updates DCT Recommendations in Response to COVID-19

Posted on by Hannah Faulkner

COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized Clinical Trials (DCT) recommendations to ensure they reflect the latest learnings and emerging best practices from the pandemic.

CTTI’s current DCT recommendations, which launched in 2018 and focus on the use of telemedicine, mobile and local healthcare providers, and related topics, were the most frequently downloaded document on CTTI’s website in 2020, reflecting the increased demand for decentralized solutions in times of COVID-19.

This new project aims to support the accelerating adoption of DCT solutions in clinical trials going forward. The updated recommendations will focus on selecting and operationalizing DCT solutions, ensuring effective safety monitoring, and appreciating the needs and perspectives of investigators, sites, and participants.

This effort builds on CTTI’s initial recognition that running a DCT does not have to be all or nothing. DCTs can be completely virtual, but many will be partially decentralized using a hybrid approach. Regardless of where a trial falls on the decentralized continuum, it is always important to:

  • Plan ahead as much as possible
  • Involve all stakeholders early and often
  • Focus on what matters
  • Communicate and be transparent

Sponsors and CROs can use the revised recommendations to design a fit-for-purpose, efficient DCT—one that can reduce patient burden, improve enrollment, and more closely replicate real-world populations and scenarios.

Recording Now Available: The State of U.S. COVID-19 Treatment Clinical Trials Public Webinar

Posted on by Hannah Faulkner

A recording for CTTI’s public webinar, The State of U.S. COVID-19 Treatment Clinical Trials, held Apr. 15, is now available. In the webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI presented findings from an analysis of data downloaded from the database for the Aggregate Analysis of ClinicalTrials.gov (AACT) on the state of U.S. COVID-19 treatment studies. The presentation included an overview of the U.S. COVID-19 clinical trials landscape, the availability of results, and changes in the portfolio as time has progressed. The presenters – Robert Califf, Verily and Google Health; Harlan Krumholz, Yale School of Medicine; and Deborah Zarin, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University – discussed how the findings from the analysis can be applied to improvements needed across the clinical trials enterprise.

View the full slide deck for the public webinar to learn more from each presenter.

For additional information on CTTI’s COVID-19 work, please visit this web page.