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

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.

Recruitment and Retention in Remote Research: Learnings From a Large, Decentralized Real-world Study

“…The adoption of digital health tools to develop and deploy digitally augmented trials has been rising steadily since the first fully remote decentralized trial in 2011 [ 6 - 8 ]. Recent studies have shown the benefits of remote monitoring using smartphones for assessing real-world behavior [ 9 , 10 ], for managing chronic pain [ 11 ], cancer care [ 12 ], diabetes [ 13 ], Parkinson symptom severity [ 14 ], and cardiovascular health [ 15 ] and for the delivery of remote interventions [ 16 ]. The COVID-19 pandemic has further accelerated this growth, enabling over 220 digitally augmented trials in 2021 alone [ 17 , 18 ].…”

Exploring patient experiences with a telehealth approach for the PRO-ACTIVE trial intervention in head and neck cancer patients

“…A telehealth approach may provide an alternate model to support patients in areas with constraints for intensive in-person cliniciandirected therapy [16]. It also has the potential to improve patient access to cancer care [17] and clinical trials participation [18].…”

A capability framework to inform the fundamental requirements for clinical trial unit development, growth and long term success in outer metropolitan and rural areas

“…Clinical trials require institutions with facilities (e.g., clinics, laboratories. pharmacies), infrastructure (e.g., records management systems, financial management systems), and trained research professionals (e.g., physicians, research nurses, clinical trial coordinators, laboratory and radiology technicians, data managers) capable of executing their roles in compliance with regulatory and ethical guidelines [ 11 ]. Health service executive teams also require support and mentoring to implement clinical trial programs.…”