Planning Decentralized Trials

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. 

CTTI Launches New Online Digital Health Trials Hub

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CTTI Project: Developing Novel Endpoints, Planning Decentralized Trials

Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.

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Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub

Posted on by kristi.geercken@duke.edu

A recording of CTTI’s April 6 public webinar introducing the new Digital Health Trials Hub is now available. The one-hour webinar includes presentations from Megan Doyle, Amgen, and Jörg Goldhahn, ETH Zurich; a stakeholder panel featuring Phil Green, CTTI, Elizabeth Kunkoski, FDA, Jeremy Wyatt, ActiGraph, and Reem Yunis, Medable; and a Q&A session moderated by Lindsay Kehoe, CTTI.

CTTI’s Digital Health Trials Hub features new and enhanced resources to help sponsors, investigators, CROs, and technology providers design and run quality, patient-centered clinical trials. The new Hub resources include significantly updated recommendations, revised reference documents, a Question Bank for Identifying Meaningful Outcome Measures, and a Process Map for the development of digitally derived endpoints. These resources are the culmination of CTTI’s 2021 Digital Health Trials work, which highlighted importance of early stakeholder engagement and flexible, tailored approaches to trial design and conduct.

The materials in the new Hub are broken down into six core areas of Digital Health Trial design and conduct:

  • Developing Novel Endpoints
  • Planning Decentralized Trials
  • Selecting & Testing Digital Health Technology
  • Managing Data
  • Interacting with Regulators
  • Supporting Sites

View the slide deck to read more.