Involving those with a lived experience of the relevant condition in the design of clinical research ensures that studies address real-world needs and priorities, enabling more relevant, ethical, and impactful outcomes. In 2019, the Breast International Group (BIG) established the BIG Patient Partnership to facilitate the meaningful involvement of people affected by breast cancer in the design and conduct of its studies. The members provide a strong international patient voice in academic breast cancer research. The partnership is based on 4 pillars: foundational and ongoing training, meaningful and systematic involvement, patients as a strategic driving force in BIG’s research, and promoting the value of the patients’ voice in research. In this paper, we describe a model to enable performing transnational clinical research for and with patient partners. We hope to inspire organizations and people who are burdened by cancer from different cultural backgrounds to develop an interactive, engaging, and empowering process for researchers and patient partners to work together.

e23009 Background: BIG is a global network of > 50 academic research groups conducting large multinational breast cancer (BC) trials. BIG has worked with patient advocates since its inception in 1999. In 2019, the BIG Patient Partnership Initiative (PPI) was launched to deepen the involvement of patient advocates and ensure their perspectives are considered throughout BIG’s research. Many BIG PPI activities have been made possible by EU4Health grants. Methods: To formalize the PPI, a Charter was co-developed by a core team from the BIG headquarters (HQ) and Executive Board (EB), in consultation with patient partners, defining its governance and function. To enable continuous input on all BIG trials, patient partners attend BIG Scientific Meetings where new study proposals are presented. ‘Input Meetings’ are then held to discuss a trial concept with lead investigators, gathering feedback on research questions, study design, eligibility criteria, and endpoints. 1-2 patient partners continue as part of study committees. To inform strategic decision-making, a better understanding of patient partners’ views on various aspects of BC research is sought via virtual and in-person meetings, surveys, and other formats. The insights gathered are shared with the BIG EB. Patient partners also participate in BIG’s scientific activities such as task forces and the BIG-NCTN Annual Meeting. Results: 12 patient partners from 9 countries are currently part of the BIG PPI. Discussions identified 4 pillars for meaningful patient involvement: comprehensive training, systematic integration into BIG’s activities, active participation in strategic planning, and advocacy for patient-centric research within and beyond BIG. 13 training modules have been conducted, covering topics from breast cancer biology and treatment to clinical trial design. 5 Input Meetings have been held leading to the adaptation of 3 new BIG trials to better reflect patient needs. Currently, 7 patient partners are A patient-focused checklist for new trial ideas has been co-developed with the patient partners and piloted with 3 study proposals. Starting in 2025, BIG patient partners will hold 2 seats on the BIG EBA research priorities survey and a research landscape analysis have been conducted with patient partners, BIG HQ, and EB members. Conclusions: BIG is committed to research for and with patients, involving patient advocates who represent the global patient community in its strategy and prioritizing research questions that matter most to them. BIG’s Patient Partnership has evolved as a model for the inclusion of patient advocates in research to develop better trials, which could be applied to other diseases. Support from the European Union has enabled the continued meaningful patient involvement within BIG.

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.

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.