新的调查问题 AstraZeneca的ticagrelor批准, 指出关键审判数据存在差异。
New investigation questions AstraZeneca's ticagrelor approval, citing discrepancies in key trial data.
美国"英国医学杂志" (BMJ) 的新调查引发了对阿斯德拉泽内卡抗血小板药物提卡格勒尔 (ticagrelor) 批准的临床试验的担忧.
A new investigation by The BMJ raises concerns about the clinical trial that approved AstraZeneca's anti-platelet drug ticagrelor.
尽管2009年PLATO试验显示,与克洛皮多格勒相比,提卡格勒减少了血管原因的死亡,但FDA在自己的医疗官员的反对意见下批准了它.
Despite the 2009 PLATO trial showing ticagrelor reduced deaths from vascular causes compared to clopidogrel, the FDA approved it over objections from its own medical officer.
自获得批准以来,其他研究未能复制PLATO的结果,而BMJ发现死亡报告存在差异,质疑药物的功效和批准程序。
Since approval, other studies failed to replicate the PLATO results, and The BMJ found discrepancies in death reporting, questioning the drug's efficacy and approval process.