Clinical Trials Ontario

Participant Experience Toolkit

Decentralized and Hybrid Clinical Trials

Decentralized clinical trials and hybrid components of clinical trials are becoming more common.

Health Canada defines decentralized clinical trials as ““…trials conducted with study participants located outside of clinical research centres for all of the required trial procedures”.

Hybrid trials are not completely decentralized, so may have some elements done at a central site, others done at home or close to home, etc.

While decentralizing all or some parts of a clinical trial may make participating in trials more convenient, they also require different operational and administrative approaches. The considerations and resources here are intended to help anyone who is interested in participating in or conducting trials with decentralized components.

Note that this part of the Toolkit is a work in progress. We invite you to check back for updates to it periodically.

These are listed based on what your perspective or role is in the clinical trial space.

Potential Participant or Participant (Including Family Members and Caregivers)
  • Understand the difference between centralized and hybrid or decentralized clinical trials
  • Consider how your participation may be affected by decentralized or hybrid components. These might include knowing what supports are available, what technologies might be used (including the internet), how you will interact with the trial team, and more
  • Ask who your trial contact is
Investigators and Research Teams
  • Work with patients and caregivers who can bring their perspectives to the team, and engage them from the idea stage
  • Be prepared for and consider how to support participants
  • Start planning early, and consider the budget, operational approach, resources, population, consent possibilities, data security and plans, etc.
  • Contact your research ethics board (REB) to understand any guidance they may have (e.g., potentially relating to consent, data collection, etc.)
  • Consider how or if sponsors can provide additional support to enable these types of trials
  • Be prepared for and consider how to support participants
  • Think about even small things that could be decentralized and ease the burden of participating (e.g., taking some measurements at home that are supervised or trained by someone virtually).
Research Ethics Boards (REB)
  • Share guidance about decentralized or hybrid components of trials with research teams
  • Opportunities to collaborate on unified REB guidelines and review strategies for trials with decentralized or hybrid components
Sponsors
  • Work with patients and caregivers who can bring their perspectives to the team, and engage them from the idea stage
  • Embed decentralized clinical trials elements into a generic protocol document (which has been reviewed by Health Canada and REBs)
  • Create contracts or contract templates that consider all potential decentralized elements to facilitate approval
  • Ensure suitability and accessibility of the technology being considered
  • Consider how budget needs may be affected by decentralized components
  • Decentralized Trials Resource Guide provides information and resources on a collection of key considerations and methods for decentralized clinical trials processes. This guide is the result of a collaboration in Ontario and is intended for institutions, research departments, sponsors and CROs that may be looking to implement DCT approaches.
  • 3CTN CRAFT Framework is the Canadian Remote Access Framework for Clinical Trials (CRAFT), developed by the Canadian Cancer Clinical Trials Network (3CTN). The aim of CRAFT is to bring high-quality trial options to underserved communities by engaging local care providers and enabling decentralized trial delivery. The link provided here includes background information and a short video on CRAFT along with access to the CRAFT Toolkit which includes a number of templates for operationalizing the framework.
  • Remote monitoring: Tips & Tricks from both sides of the screen is a recording of a presentation about peer to peer and remote monitoring presented by Dr. Eileen Morrison, C17 Research Manager, and Stephanie Badour, Clinical Research Unit Manager, Montreal Children’s Hospital.
  • Important Considerations for Remote Consent: What We’ve Learned from the ACT II Study is a recording of a presentation where Speakers from Southlake and the Population Health Research Institute share their experience and learnings using remote consent within a DCT study model, focusing on rapport with participants, privacy, and processes used.
  • Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: “It’s About Time we Bring Trials to People” is a peer-reviewed, published paper on research Clinical Trials Ontario undertook in collaboration with patient and public partners to understand perceptions in Canada relating to decentralized trial components and participation.
  • Decentralized Trials & Research Alliance (DTRA) is a collaboration of members representing industry, regulatory authorities, patient advocacy organizations and research sites. Their website provides tools, educational resources, a glossary of terms and best practices aimed at accelerating the adoption of patient-focused decentralized clinical trials.

     

Note: This resource list is not exhaustive and listing a resource does not denote its endorsement or promotion.