Department of Pharmacy, Texas Health Presbyterian Hospital Dallas. TX, USA.
Ann Pharmacother. 2012 Nov;46(11):1564-7. doi: 10.1345/aph.1Q780. Epub 2012 Nov 7.
On October 25, 2011, Eli Lilly and Company announced the voluntary withdrawal of Xigris (drotrecogin alfa [activated]) following the negative results of its most recent clinical trial, the PROWESS-SHOCK study. The purpose of this commentary is to briefly review the history of drotrecogin alfa, discuss issues surrounding early cessation of clinical trials for benefit, and highlight the scientific and ethical dilemmas faced when deciding whether or not to stop a trial early for benefit. This review should serve as an introduction to the topic of stopping trials early for benefit.
2011 年 10 月 25 日，礼来公司宣布其最新临床试验 PROWESS-SHOCK 研究结果为阴性后，自愿撤回 Xigris（重组人活化蛋白 C）。本文旨在简要回顾重组人活化蛋白 C 的历史，讨论临床试验因获益而提前终止的相关问题，并强调在决定是否因获益而提前终止试验时所面临的科学和伦理困境。本文旨在作为提前终止获益临床试验这一主题的介绍。
