Davidoff Cancer Center, Rabin Medical Center-Beilinson Hospital, 49100, Petah Tikva, Israel.
Department of Precision Oncology, University Hospital of Campania L. Vanvitelli, Naples, Italy.
J Transl Med. 2022 Dec 13;20(1):593. doi: 10.1186/s12967-022-03744-6.
In this commentary, using existing clinical trial data and FDA approvals we propose that there is currently a critical need for an appropriate balancing between the financial impact of new cancer drugs and their actual benefit for patients. By adopting "pleural mesothelioma" as our clinical model we summarize the most relevant pertinent and available literature on this topic, and use an analysis of the reliability of the trials submitted for registration and/or recently published as a case in point to raise concerns with respect to appropriate trial design, biomarker based stratification and to highlight the ongoing need for balancing the benefit/cost ratio for both patients and healthcare providers.
在这篇评论中，我们利用现有的临床试验数据和 FDA 批准，提出目前迫切需要在新药的财务影响和对患者的实际益处之间取得适当平衡。我们选择“胸膜间皮瘤”作为临床模型，总结了关于这一主题的最相关、最适用的文献，并对提交注册和/或最近发表的试验的可靠性进行分析，以此为例，提出对适当的试验设计、基于生物标志物的分层的关注，并强调需要继续平衡患者和医疗保健提供者的获益/成本比。
