Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials

摘要: Though patient engagement in clinical research is growing, recent reports suggest few trials report on such activities. To address this gap, we describe our approach to the development of a trial protocol assess a new immunotherapy for blood cancer (chimeric antigen receptor T-cell therapy, CAR-T cell therapy). Our team developed by working with partners from inception. Two lived experience were identified through referrals team’s professional network and organization contacts. onboarded engaged several studies conducted develop protocol, including systematic review existing literature interviews survey obtain perspectives barriers enablers participating trial, an early economic analysis, retrospective cohort study. Engaging enhanced ways that would not have otherwise occurred. By selecting important outcomes data collection, helped flag quality life health utility measures been reported previous therapy cancer. also co-developed non-technical summary summarized results accessible manner. reviewed interview questions, improve language appropriateness; provided recruitment suggestions; perspective results, thereby confirming importance findings. Input was obtained costs analysis. may be burden both patients caregivers during confirm overall structure model reflected care pathway. shared their diagnosis treatment stories, which provide insight into experience. Contributions invaluable each component study, as well protocol. We plan use future order to meaningfully engage other trials; hope reporting methods will help teams do same. Affiliated NCT03765177 .