Facilitating meaningful patient involvement in the design and conduct of cancer research: The Breast International Group (BIG) patient partnership model.

Abstract

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.