This guide provides information and resources on a collection of key considerations and methods for conducting decentralized clinical trials (DCT) processes. The aim of this guide is to form a common framework of practices and to harmonize approaches to decentralized solutions in Ontario. This guide is intended for institutions, research departments, sponsors and CROs that may be looking to implement DCT approaches.
Clinical trial activity in Ontario, and worldwide, has been impacted by the COVID-19 pandemic. Since the onset of the pandemic, clinical trial sites and sponsors have been tasked with the challenge of conducting clinical trials safely in our current reality. Many sites and sponsors have implemented digital, virtual and decentralized processes and workflows in order to safely run clinical trials during the pandemic.
Increasingly, decentralized trial strategies are being seen not just as an immediate risk mitigation tactic during the pandemic, but as a highly effective approach to conducting clinical trials under “new normal” circumstances. Clinical trial participants have long been calling for more participant-centric approaches which would allow trial participants to engage in clinical trials on their own terms through digital and virtual means. Decentralized trials are a more participant-centric approach which reduces barriers and burdens to trial participation and offers greater access and equity in clinical trials.
The clinical trials community in Ontario now has an opportunity to build on the digital and virtual solutions in place and move toward more decentralized trial approaches to trials. In an effort to establish Ontario as a world leader this changing context, Clinical Trials Ontario has brought together key stakeholders from industry, institutions, REBs and participants to address considerations and create tools for increased alignment and transparency in approaches to decentralized trials.
Working with this community, six key practices were recognized as important to decentralized trials: eConsent; Remote Consent; eRecruitment; Direct to Participant Investigational Product; Principal Investigator (PI) Oversight; and Remote Study Monitoring.