PURPOSE Although new therapeutic options continue to improve disease-related outcomes in advanced breast cancer (ABC), enhanced focus is needed to improve quality of life for patients currently living with ABC. METHODS In November 2019, a multidisciplinary workshop to explore patient perceptions of their information and support needs was held at the ABC Global Alliance Annual Meeting in Lisbon, Portugal. Ninety-two attendees from 27 countries participated in the workshop. RESULTS Several key unmet needs were identified and discussed in the workshop, including the following: (1) Significant patient knowledge gaps exist related to the diagnosis and management of ABC, and the availability of patient-focused information to support these gaps in knowledge remains limited. (2) The development of meaningful relationships between patients and health care professionals, and the role of patients in decision making, is often overlooked for patients with ABC. (3) Multidisciplinary care approaches are crucial for patients with ABC; however, these often lack effective coordination. (4) Access to clinical trials for ABC also remains limited. (5) Caregivers, friends, and family members do not receive sufficient guidance to support patients with ABC and manage their own well-being. CONCLUSION The variety of unmet needs explored in the workshop demonstrates that patients with ABC still face considerable challenges related to quality of care and support, which will not be resolved until tangible action is taken. Issues highlighted in the workshop should be prioritized by working groups to shape the development of community-based solutions. There is a need for the global community to act proactively to maximize awareness of these ongoing unmet needs and existing resources, while socializing and building new initiatives and resources that will help to close these gaps for patients.

No abstract

e14084 Background: Evidence-based guidance on how to best facilitate patient engagement in the drug development process is lacking1,2.Well-informed, engaged patients and advocates can contribute meaningfully throughout drug development process for new therapeutics3. Regulatory agencies, including the FDA and EMA, concur4,5. However, identifying and effectively implementing meaningful, and structured patient engagements has been challenging for research organizations6. Methods: Patient advocates with deep knowledge of the special needs of patients within their respective disease areas and experience in patient-centered research and programming were identified by the patient relations’ team of the organization. Participating advocates were generally contracted for consulting support across the development lifecycle to provide timely feedback for emerging topics and agreed to provide feedback within a 3-4 week timeframe to requests for support. Called “Global Oncology Patient Insight Panel” (GOPIP), the approach facilitated fast-moving development teams to quickly engage advocates for advice while enabling projects remain on timeline. GOPIP members engaged with teams within the organization on an ad-hoc basis across the drug development process, as early as protocols’ and informed consents’ review and PRO selection, among many others patient-centered projects. Results: GOPIP engagements included 49 advocates from 19 countries, across 14 disease areas, in the program’s first 18 months. 54 projects were completed. Multiple engagements for three clinical trials, part of the development program, have been accomplished. Seven plain language summaries of published data results were reported publicly with consultants’ input. Satisfaction was high among advocates as well as internal teams. Conclusions: The Patient Insight Panel model is a valuable resource to facilitate patient engagement efforts. More research is needed to evaluate the outcomes and effectiveness of the method. References: 1. Chalasani, M., et al. 2018. Res Involv Engagem. 4,10 2. de Wit, M., et al. 2019. The Lancet, 393(10176),1095-1096 3. Kuehn, C. M. 2018. Ther. Innov. Regul. Sci., 52(5),661–668 4. FDA. 2020. https://www.fda.gov/about-fda/oncology-center-excellence/patient-focused-drug-development . Accessed February 8, 2020 5. EMA. 2016. https://www.ema.europa.eu/en/documents/other/appendix-2-guideline-evaluation-anticancer-medicinal-products-man_en.pdf Accessed February 8, 2020 6. Geissler, J., et al. 2017. Ther. Innov. Regul. Sci., 51(5),612-619.