How to improve metastatic pancreatic ductal adenocarcinoma patients’selection:Between clinical trials and the real-world

As underlined in the minireview by Blomstrand et al,given the poor prognosis and the paucity of data on a therapeutic sequence in pancreatic ductal adenocarcinoma(PDAC),additional randomized controlled trials and real-world evidence studies addressing current and novel regimens are needed.The real-world outcomes of first-line chemotherapy regimens such as FOLFIRINOX and gemcitabine/nab-paclitaxel are thoroughly reviewed and seem to be largely generalizable in a real-world context.Regarding second-line chemotherapy,the key question about the optimal sequence of regimens remains uncertain.Precisely in this setting,it is therefore useful to encourage the implementation of clinical studies that may contribute to the scarcity of data available up to now.We report our experience with a small group of patients treated with second-line liposomal irinotecan(nal-IRI)plus 5-fluorouracil and leucovorin.To improve the treatment of patients affected by PDAC,it is useful to identify subgroups of patients who may benefit from target treatments(e.g.,BRCA mutant)and it is also important to focus on any prognostic factors that may affect the survival and treatment of these patients.

真实世界数据在上市后药品安全性研究中的伦理风险

目的为更好地利用符合伦理要求的真实世界数据(real-world data,RWD)开展上市后药品安全性监测和评价。方法从患者安全和数据安全的维度出发,探讨RWD在研究方案中的伦理要求、研究注册和发表的伦理要求、以及数据归属和数据使用权限的伦理考虑。结果与结论建议对真实世界研究(real-world study,RWS)中伦理问题立法并制定政策,同时加强对RWD伦理审查形式创新等相关问题的研究。