Craft—a proposed framework for decentralized clinical trials participation in Canada

Stephen Sundquist, Gerald Batist, Kathy Brodeur‐robb, Kathryn Dyck, Bernhard J. Eigl, David K. Lee, Jaqueline Limoges, Holly Longstaff, Jim Pankovich, Anna Sadura, Patrick Sullivan, Janet E. Dancey

Research output: Contribution to journalReview articlepeer-review

21 Citations (Scopus)

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 stake-holders 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.

Original languageEnglish
Pages (from-to)3857-3865
Number of pages9
JournalCurrent Oncology
Volume28
Issue number5
DOIs
Publication statusPublished - 2021

Keywords

  • CRAFT
  • Canada
  • Decentralized clinical trials
  • Remote trial access
  • Remote trial framework
  • Remote trial management
  • Trial cluster

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