Planning Decentralized Trials

Legal & Regulatory Issues Affecting the Adoption of Mobile Clinical Trials

JULY 11, 2017 TO JULY 12, 2017

CTTI Project: Supporting Decentralized Trial Approaches

Meeting Objectives

  • Present findings from evidence gathering activities
  • Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile technology in clinical trials
  • Describe what products CTTI should develop to equip change agents to overcome the legal and regulatory barriers that inhibit more widespread use of mobile technology in clinical trials, including for the purposes of regulatory submission

Meeting Location:

Sheraton Silver Spring Hotel 8777 Georgia Ave, Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to the Clinical Trials Transformation Initiative by Annemarie Forrest
  2. Offsite Trials by Leonard Sacks
  3. Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
  4. Qualitative Sponsor Interview Findings by David Babaian
  5. On the Ground and In the Cloud: Lessons Learned from Operating DCTs by Laura Podolsky
  6. Combining Crowdsourced Protocol Design and Digital Study Execution by Marc Foster
  7. Advancing Patient-Centered Clinical Trials by Implementing At-home Study Visits by Gail Adinamis
  8. Conducting Trials Remotely via Telehealth by Michael O’Brien
  9. Telehealth Public Policy Trends and Issues by Mario Gutierrez
  10. Telemedicine: Expanding Access, Protecting Patients by Lisa Robin
  11. Navigating State Telemedicine Laws by Ross Friedberg

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.

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.

CTTI Publication Explores Perceived Barriers and Recommendations Surrounding the Adoption of Decentralization

Posted on by kristi.geercken@duke.edu

Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science, explores three perceptions that are commonly heard as barriers to the adoption of decentralized approaches in clinical trials. Because the integration of these approaches has the potential to enhance accessibility, diversity, and to reduce the burden on participants and caregivers, it is crucial to understand which barriers can be readily addressed with existing strategies.  

In this commentary, CTTI staff outline the three barriers to adoption, discuss the degree to which the perceived and real barriers can be overcome, and share existing resources sponsors and trial designers can use to address them.