CRAFT—A Proposed Framework for Decentralized Clinical Trials Participation in Canada

We are excited to announce that the “CRAFT—A Proposed Framework for Decentralized Clinical Trials Participation in Canada” has been published in Current Oncology and is available to read online. This is the result of the hard work of the CRAFT initiative steering committee and working group members and support from our funders and stakeholders towards establishing a novel, decentralized approach to providing more equitable access to clinical trials for patients from across the country.

Abstract: Canada’s vast geography, and centralized delivery of cancer care and clinical trials create barriers for trial participation for patients in remote and rural settings. The development and implementation of a framework that enables safe and regulatory compliant trial participation through local healthcare providers would benefit Canadian patients, clinicians, trial sponsors and the health care system. To address this issue, representatives of Canada’s cancer clinical trial community met to identify key challenges and develop recommendations for remote patient participation in trials. A structured literature review identified remote/rural trial delivery models. A panel of expert stakeholders reviewed the models and participated in a workshop to assess health system readiness, identify needed processes, tools and mechanisms, and develop recommendations for a Canadian framework for decentralized clinical trial conduct. The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a risk-based approach used by site investigators to delegate responsibilities for a given trial to satellite health centres within a hub-and-spoke “trial cluster”. The Framework includes specific recommendations to ensure research experience, capacity, regulatory compliance and patient safety. Canada’s cancer care and telemedicine systems can be leveraged to enable broader access to clinical trials for patients who are geographically remote from cancer centres. CRAFT’s risk-based framework is based on other successful models of remote trial patient management and is in the pilot implementation phase in Canada.

Sundquist S, Batist G, Brodeur-Robb K, Dyck K, Eigl BJ, Lee DK, Limoges J, Longstaff H, Pankovich J, Sadura A, Sullivan P, Dancey JE. CRAFT—A Proposed Framework for Decentralized Clinical Trials Participation in Canada. Current Oncology. 2021; 28(5):3857-3865.

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