How to optimize the CAR-T Cell therapy process? A group concept mapping analysis of preconditions for a frictionless process from a German multistakeholder perspective.

Treatment with chimeric antigen receptor T (CAR-T) cells involves a large number of interdisciplinary stakeholders and is associated with complex processes ranging from patient-specific production to follow-up care. Due to the complexity, maximum process optimization is required in order to avoid efficiency losses. This study aimed at systematically determining the preconditions for a frictionless flow of the CAR-T process by surveying the stakeholders involved. A Group Concept Mapping (GCM) analysis, a mixed-methods participatory research, was conducted. CAR-T experts from different professional backgrounds went through three steps: 1) Brainstorming relevant aspects (statements) for a frictionless process, 2) Sorting the collected statements based on their similarity, and 3) Rating the importance and feasibility of each statement. A cluster map reflecting the overarching topics was derived, and mean ratings per statement and cluster were calculated. Overall, 20 CAR-T experts participated. A total of 80 statements were collected, resulting in a map of the following 10 clusters (mean importance/feasibility): Information for patients and physicians (4.16/3.77), Supportive network (4.03/3.53), Eligibility of patients (4.41/3.63), Evidence, transparency and communication (4.01/3.33), Paperwork (4.1/2.52), Interface with pharmaceutical manufacturer (4.03/2.85), Reimbursement (4.29/2.31), Quality Management (4.17/3.18), Infrastructure of CAR-T clinics (4.1/2.93), and Patient-oriented processes (4.46/3.32). The 80 statements underlined the complex and manifold nature of the CAR-T treatment process. Our results reflect the first step in overcoming hurdles: identifying potential hurdles and required preconditions. Decision-makers and stakeholders can use the results to derive strategies and measures to further promote a frictionless process.

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Copyright © 2024 Siefen, Kurte, Jakobs, Teichert, von Tresckow, Reinhardt, Holtick, Atta, Jehn, Sala, Warnecke, Hänel, Scheid and Kron.

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A-CS, MK, and FK are employees of VITIS Healthcare Group, which was sponsored by Gilead Sciences GmbH in connection with the development of this manuscript. FJ received consulting fees or honorarium for participation on an Advisory Board from Alexion, Cerus, Noscendo, Novartis, Pfizer, Seagen. BT is an advisor or consultant for Allogene, Amgen, BMS/Celgene, Cerus, Gilead Kite, Incyte, IQVIA, Janssen-Cilag GmbH, Lilly, Merck Sharp & Dohme, Miltenyi, Novartis, Noscendo, Pentixapharm, Pfizer, Pierre Fabre, Qualworld, Roche, Sobi and Takeda; has received honoraria from AbbVie, AstraZeneca, BMS/Celgene, Gilead Kite, Incyte, Lilly, Merck Sharp & Dohme, Novartis, Roche Pharma AG and Takeda; reports research funding from Esteve Inst, Merck Sharp & Dohme Inst, Novartis Inst, and Takeda Inst; and reports travel support from AbbVie, AstraZeneca, Gilead Kite, Lilly, Merck Sharp & Dohme, Pierre Fabre, Roche, Takeda, and Novartis. HR received consulting and lecture fees from AbbVie, AstraZeneca, Roche, Janssen-Cilag, Novartis, Vertex and Merck. HR received research funding from Gilead and AstraZeneca. HR is a co-founder of CDL Therapeutics GmbH. UH reports honoraria/consultancies from BMS, Kite/Gilead, Miltenyi Biotec, and Novartis. CJ reports honoraria/consultancies from Gilead/Kite, BeiGene, Janssen, and BMS. ES reports honoraria/consultancies from MSD, BMS, Jazz Pharmaceutical, Kite Gilead, Therakos Mallinckrodt. AW reports honoraria from Kite/Gilead and BMS. MH is an advisor or consultant for Pfizer, Incyte, Sanofi/Aventis, Roche, Amgen, Sobi, Janssen, Sobi, BMS, Kite/Gilead. MH reports honoraria from Sobi, Novartis, Gilead, Falk Foundation, BMS. CS received honoraria/travel support from Amgen, BMS, MSD, Janssen, Pierre Fabre, Sanofi, Gilead. CS reports research funding from Janssen, Novartis, BMS, and Takeda; has received honoraria/travel support from Abbvie and Roche. MT has received honoraria from Bristol Myers Squibb and Janssen Cilag. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Gilead Sciences GmbH. The funder had the following involvement in the study: Representatives of the funder participated in the Group Concept Mapping survey. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.