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.
A PROPOSED RUBRIC FOR PATIENT ENGAGEMENT IN DRUG DEVELOPMENT: WHAT CONSTITUTES “SOUND” ENGAGEMENT?
