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.

The COVID-19 pandemic resulted in temporary holds placed on new trial startups, patient recruitment and follow up visits for trials which contributed to major disruptions in cancer center trial unit operations. To assess the impact, the Canadian Cancer Clinical Trials Network (3CTN) members participated in regional meetings and a survey to understand the impact of the pandemic to academic cancer clinical trials (ACCT) activity, cancer trial unit operations and supports needed for post-pandemic recovery. Trial performance and recruitment data collected from 1 April 2020–31 March 2021 was compared to the same period in previous years. From 1 April–30 June 2020, patient recruitment decreased by 67.5% and trial site activations decreased by 81% compared to the same period in 2019. Recovery to reopening and recruitment of ACCTs began after three months, which was faster than initially projected. However, ongoing COVID-19 impacts on trial unit staffing and operations continue to contribute to delayed trial activations, lower patient recruitment and may further strain centers’ capacity for participation in academic-sponsored trials.

Introduction Clinical trials, although academically accepted as the most effective treatment available for cancer patients, poor accrual to clinical trials remains a significant problem. A clinical trials navigator (CTN) program was piloted where patients and/or their healthcare professionals could request a search and provide a list of potential cancer clinical trials in which a patient may be eligible based on their current status and disease. Objectives This study examined the outcomes of a pilot program to try to improve clinical trials accrual with a focus on patients at medium to small sized cancer programs. Outcomes examined included patient disposition (referral to and accrual to interventional trials), patient survival, sites of referral to the CTN program. Methods One 0.5 FTE navigator was retained. Stakeholders referred to the CTN through the Canadian Cancer Clinical Trials Network. Demographic and outcomes data were recorded. Results Between March 2019 and February 2020, 118 patients from across Canada used the program. Seven per cent of patients referred were enrolled onto treatment clinical trials. No available trial excluded 39% patients, and 28% had a decline in their health and died before they could be referred or enrolled onto a clinical trial. The median time from referral to death was 109 days in those that passed. Conclusion This novel navigator pilot has the potential to increase patient accrual to clinical trials. The CTN program services the gap in the clinical trials system, helping patients in medium and small sized cancer centres identify potential clinical trials at larger centres.

Background—to guide the implementation of patient centricity and engagement in cancer clinical trials (CTs) and to operationalize the Canadianized version of the Clinical Trials Transformation Initiative (C-CTTI) model, the development of a charter was identified by cancer CT stakeholders. Methods—the Canadian Cancer Trial Stakeholder Charter (the Charter) was initiated by Colorectal Cancer Canada (CCC) and developed via the—1—formation of an inclusive working group (WG) that drafted the document using recommendations collected during the development of the C-CTTI model; 2—socialization of the draft Charter to solicit feedback from cancer CT stakeholders, including those who attended the 2019 CCC Conference; and 3—incorporation of stakeholders’ feedback and finalization of the Charter by the WG. Results—the Charter was built around five guiding principles—1—patient centricity; 2—commitment to education and training; 3—collaboration as equal and independent partners in research; 4—transparency and accountability; and 5—high standards in data collection integrity and honesty. These principles led to the Charter’s five tenets, which stipulate stakeholder commitments, aiming to make CTs accessible to all patients, improve the design and implementation of CTs to benefit patients, expand recruitment and retention of patients in CTs, and further advance cancer research and treatment. Conclusions—the Charter is intended to integrate the patient voice into the Canadian cancer CT continuum. The next phases of the C-CTTI model include the adoption and implementation of the Charter, the establishment of a patient group training program, and the development of real-world evidence/real-world data methodologies.

Background In Canada, there is growing evidence that oncology clinical trials units (ctus) and programs face serious financial challenges. Investment in cancer research in Canada has declined almost 20% in the 5 years since its peak in 2011, and the costs of conducting leading-edge trials are rising. Clinical trials units must therefore be strategic about which studies they open. We interviewed Canadian health care professionals responsible for running cancer trials programs to identify the barriers to sustainability that they face. Methods One-on-one telephone interviews were conducted with clinicians and clinical research professionals at oncology ctus in Canada. We asked for their perspectives about the barriers to conducting trials at their institutions, in their provinces, and nationwide. Interviews were digitally recorded, transcribed, anonymized, and coded in the NVivo software application (version 11: QSR International, Melbourne, Australia). The initial coding structure was informed by the interview script, with new concepts drawn out and coded during analysis, using a constant comparative approach. Results Between June 2017 and November 2018, 25 interviews were conducted. Key barriers that participants identified were ■ insufficient stable funding to support trials infrastructure and retain staff; ■ the need to adopt strict cost-recovery policies, leading to fewer academic trials in portfolios; and ■ an overreliance on industry to fund clinical research in Canada. Conclusions Funding uncertainties have led ctus to increasingly rely on industry sponsorship and more stringent feasibility thresholds to remain solvent. Retaining skilled trials staff can create efficiencies in opening and running studies, with spillover effects of more trials being open to patients. More academic studies are needed to curb industry’s influence.