The inclusion of patients as partners in research is a key link in the delivery of patient-centred care in healthcare systems. Despite genuine intentions to engage patients in authentic partnerships, efforts can result in tokenism and benefits of engagement are missed. Understanding how patient engagement provides value along the research to patient-care continuum and how to best engage patients as partners are key. This document describes the method taken by the Canadian Cancer Trials Group (CCTG) to implement meaningful patient centricity and engagement and the benefits realized. Originally, Patient Representatives were recruited and assigned to CCTG Committees. Lacking guidance, the role was one of a passive meeting attendee. A gap analysis identified a need for clarity in expectations, understanding of the linkage to CCTG strategic objectives, and supporting tools and training. A plan was developed and successfully implemented in three phases, each phase building on the previous, the level of patient engagement simultaneously changing from “Inform” to “Involve” to “Collaborate” on the International Association for Public Participation (IAP2) scale. Results include significant contributions to increased patient accrual in CCTG trials, to increased CCTG grant funding, as well as recognition and adoption of these practices within Canada and internationally.

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.

In a prospective study, we sought to determine acceptability of linkage of administrative and clinical trial data among Canadian patients and Research Ethics Boards (REBs). The goal is to develop a more harmonized approach to data, with potential to improve clinical trial conduct through enhanced data quality collected at reduced cost and inconvenience for patients. On completion of the original LY.12 randomized clinical trial in lymphoma (NCT00078949), participants were invited to enrol in the Long-term Innovative Follow-up Extension (LIFE) component. Those consenting to do so provided comprehensive identifying information to facilitate linkage with their administrative data. We prospectively designed a global assessment of this innovative approach to clinical trial follow-up including rates of REB approval and patient consent. The pre-specified benchmark for patient acceptability was 80%. Of 16 REBs who reviewed the research protocol, 14 (89%) provided approval; two in Quebec declined due to small patient numbers. Of 140 patients invited to participate, 115 (82%, 95% CI 76 to 88%) from across 9 Canadian provinces provided consent and their full name, date of birth, health insurance number and postal code to facilitate linkage with their administrative data for long-term follow-up. Linkage of clinical trial and administrative data is feasible and acceptable. Further collaborative work including many stakeholders is required to develop an optimized secure approach to research. A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.