Clinical Trials Ontario (CTO) is thrilled to introduce the ACT (Advancing Clinical Trials) Initiative and the new Resource Guide for Decentralized Clinical Trial Approaches.
Throughout the COVID-19 pandemic, many sites and sponsors have implemented digital, virtual and decentralized workflows in order to safely run clinical trials. Increasingly, these 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 the “new normal” environment. Decentralized trial strategies can provide a more participant-centric approach which may reduce 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 adoption of decentralized trial approaches.
To establish Ontario as a world leader this changing context, Clinical Trials Ontario has established the ACT initiative. ACT is driven by stakeholders from industry, institutions, REBs and participants who have come together to share ideas and create tools for increased alignment and transparency in approaches to decentralized trials in Ontario.
The Resource Guide for Decentralized Clinical Trial Approaches, created by CTO and ACT, provides best practices and key considerations for conducting decentralized clinical trials (DCT). The aim of this guide is to share best practices and form a common framework to harmonize approaches to decentralized solutions in Ontario. This resource is intended for institutions, research departments, sponsors and CROs that may be looking to implement DCT approaches. 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.