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

Area of Science:

• Oncology
• Health Services Research
• Clinical Trial Management

Background:

• Canada's large geography presents challenges for remote and rural patients accessing cancer clinical trials.
• Centralized cancer care delivery creates significant barriers to trial participation for geographically isolated populations.

Purpose of the Study:

• To develop a framework for safe and regulatory-compliant clinical trial participation for remote Canadian patients.
• To address challenges in decentralized clinical trial conduct within the Canadian healthcare system.

Main Methods:

• A structured literature review identified existing remote/rural trial delivery models.
• Expert stakeholders participated in a workshop to assess readiness and develop recommendations for a Canadian framework.
• A risk-based approach was developed for delegating trial responsibilities within a hub-and-spoke model.

Main Results:

• The Canadian Remote Access Framework for clinical Trials (CRAFT) was developed.
• CRAFT utilizes a risk-based approach for investigators to delegate trial responsibilities to satellite health centers.
• Recommendations ensure research experience, capacity, regulatory compliance, and patient safety in decentralized trials.

Conclusions:

• Canada's existing cancer care and telemedicine infrastructure can facilitate broader clinical trial access for remote patients.
• The CRAFT framework, based on successful remote patient management models, is currently in pilot implementation.
• Decentralized clinical trial models are crucial for equitable access to cancer research.