Next Article in Journal
The Challenge of Return to Work after Breast Cancer: The Role of Family Situation, CANTO Cohort
Previous Article in Journal
Prognostic Radiological Tools for Clinical Stage IA Pure Solid Lung Cancer
Review

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

1
Canadian Cancer Clinical Trials Network, Toronto, ON M5G 0A3, Canada
2
Segal Cancer Centre, Jewish General Hospital, McGill University, Montreal, QC H3T 1E2, Canada
3
C17 Council for Children’s Cancer and Blood Disorders, Edmonton, AB T6G 1C9, Canada
4
CancerCare Manitoba, Winnipeg, MB R3E 0V9, Canada
5
Division of Medical Oncology, BC Cancer, Vancouver, BC V5Z 4E6, Canada
6
Health Products and Food Branch, Health Canada, Ottawa, ON K1A 0K9, Canada
7
Ontario Cancer Research Ethics Board, Toronto, ON M5G 0A3, Canada
8
Provincial Health Services Authority, Vancouver, BC V6H 4C1, Canada
9
Bold Therapeutics Inc., Vancouver, BC V6C 1E1, Canada
10
Canadian Cancer Trials Group, Queen’s University, Kingston, ON K7L 3N6, Canada
11
Team Finn Foundation, Vancouver, BC V7K 1V4, Canada
*
Author to whom correspondence should be addressed.
Curr. Oncol. 2021, 28(5), 3857-3865; https://doi.org/10.3390/curroncol28050329
Received: 13 August 2021 / Revised: 15 September 2021 / Accepted: 24 September 2021 / Published: 30 September 2021
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. View Full-Text
Keywords: decentralized clinical trials; CRAFT; remote trial framework; trial cluster; remote trial management; remote trial access; Canada decentralized clinical trials; CRAFT; remote trial framework; trial cluster; remote trial management; remote trial access; Canada
Show Figures

Figure 1

MDPI and ACS Style

Sundquist, S.; Batist, G.; Brodeur-Robb, K.; Dyck, K.; Eigl, B.J.; Lee, D.K.; Limoges, J.; Longstaff, H.; Pankovich, J.; Sadura, A.; Sullivan, P.; Dancey, J.E. CRAFT—A Proposed Framework for Decentralized Clinical Trials Participation in Canada. Curr. Oncol. 2021, 28, 3857-3865. https://doi.org/10.3390/curroncol28050329

AMA Style

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. https://doi.org/10.3390/curroncol28050329

Chicago/Turabian Style

Sundquist, Stephen, Gerald Batist, Kathy Brodeur-Robb, Kathryn Dyck, Bernhard J. Eigl, David K. Lee, Jaqueline Limoges, Holly Longstaff, Jim Pankovich, Anna Sadura, Patrick Sullivan, and Janet E. Dancey 2021. "CRAFT—A Proposed Framework for Decentralized Clinical Trials Participation in Canada" Current Oncology 28, no. 5: 3857-3865. https://doi.org/10.3390/curroncol28050329

Find Other Styles

Article Access Map by Country/Region

1
Back to TopTop