Ballhausen Hendrik, Corradini Stefanie, Belka Claus, Bogdanov Dan, Boldrini Luca, Bono Francesco, Goelz Christian, Landry Guillaume, Panza Giulia, Parodi Katia, Talviste Riivo, Tran Huong Elena, Gambacorta Maria Antonietta, Marschner Sebastian
Ludwig-Maximilians-Universität München, Munich, Germany.
Department of Radiation Oncology, LMU University Hospital, LMU Munich, Munich, Germany.
NPJ Digit Med. 2024 Oct 14;7(1):280. doi: 10.1038/s41746-024-01293-4.
In multicentric studies, data sharing between institutions might negatively impact patient privacy or data security. An alternative is federated analysis by secure multiparty computation. This pilot study demonstrates an architecture and implementation addressing both technical challenges and legal difficulties in the particularly demanding setting of clinical research on cancer patients within the strict European regulation on patient privacy and data protection: 24 patients from LMU University Hospital in Munich, Germany, and 24 patients from Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy, were treated for adrenal gland metastasis with typically 40 Gy in 3 or 5 fractions of online-adaptive radiotherapy guided by real-time MR. High local control (21% complete remission, 27% partial remission, 40% stable disease) and low toxicity (73% reporting no toxicity) were observed. Median overall survival was 19 months. Federated analysis was found to improve clinical science through privacy-friendly evaluation of patient data in the European health data space.
在多中心研究中,机构间的数据共享可能会对患者隐私或数据安全产生负面影响。一种替代方法是通过安全多方计算进行联合分析。这项试点研究展示了一种架构和实施方案,该方案在欧洲关于患者隐私和数据保护的严格法规下,应对癌症患者临床研究这一特别苛刻环境中的技术挑战和法律难题:德国慕尼黑路德维希 - 马克西米利安大学医院的24名患者和意大利罗马阿戈斯蒂诺·杰梅利大学综合医院的24名患者接受了肾上腺转移瘤治疗,采用实时磁共振引导下的在线自适应放疗,通常为40 Gy,分3或5次照射。观察到较高的局部控制率(21%完全缓解,27%部分缓解,40%病情稳定)和较低的毒性(73%报告无毒性)。中位总生存期为19个月。研究发现,联合分析通过在欧洲健康数据空间中以隐私友好方式评估患者数据,改善了临床科学。