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 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. 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 a decentralized trial approach.
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 in Ontario.
This guide provides best practices and key considerations for conducting decentralized clinical trials (DCT). 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.
ACT is made up of stakeholders from industry, institutions, REBs and participants who have come together to address considerations and to create tools for increased alignment and transparency in approaches to decentralized trials in Ontario.
ACT has three subgroups working on solutions for a decentralized trial approach to clinical trials: a Privacy and IT Subgroup, a Site Self Governance Subgroup and a Principal Investigator Oversight Subgroup.
"It is our social responsibility as a research community to rethink our approach to clinical trials to allow more choice and opportunities for participants and caregivers. We cannot afford to not embrace change and we must break free from the status quo as we are competing on a global stage."