Digital Health Trials

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.

Preliminary Evidence from Sponsors & Investigators Using Mobile Devices

CTTI Project: Digital Health Trials

Webinar Presenters:

Project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips)

Webinar Objective:

In this webinar, project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips) provide an update on CTTI’s Mobile Devices Project, which focuses on scientific and technological challenges affecting the selection and use of mobile technologies in clinical research. The presenters share preliminary evidence gathered from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. Issues addressed in the webinar include:

  • Challenges affecting data management, validation, analysis, and security in mobile technologies;
  • Scientific and technical considerations in mobile device selection; and
  • Approaches to managing and reporting safety signals and adverse events.

Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials

Posted on by kristi.geercken@duke.edu

A new CTTI publication, published in Nature Reviews Bioengineering, reviews opportunities for and challenges to using digital health technologies in clinical trials and highlights CTTI’s Digital Health Trials (DHTs) Hub. Digital health technologies have the potential to transform evidence generation in clinical trials, from trial design and participant screening to data capture and analysis. However, digital health technologies introduce new challenges, including concerns around data protection and data quality. The wide variety of available technologies requires that sponsors carefully identify meaningful measures, select and test appropriate technologies for capturing these measures, and train site staff and participants to properly use the selected technologies.

CTTI’s DHT Hub includes tools and recommendations for developing novel endpoints, planning decentralized trials, selecting and testing digital health technologies, managing data, supporting sites, and interacting with regulators. These resources support the effective implementation of DHTs to bring therapies to patients more quickly and efficiently, aligning with CTTI’s Transforming Trials 2030 vision.

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.