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Accelerated virtual evaluation Increased threat to patient safety

机译:加速虚拟评估增加对患者安全的威胁

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The evaluation of a new drug follows a process which has been established over decades and in the light of many health disasters: preclinical studies, in particular animal studies; then initial trials in healthy volunteers (phase I); then the experimental phase with non-comparative trials and the first comparative trials in a limited number of patients (phase II); and finally comparative trials against reference treatments or placebo aimed at confirming hypotheses (phase III). In the 1990s, it was acknowledged that the efficacy of a new drug should be proven by at least two comparative trials against the reference treatment. For some years now, however, market authorisation (MA) is frequently granted on the basis of a single phase III comparative trial, or even phase II trials, as is the case for daratumumab as monotherapy for multiple myeloma (see Prescrire International N° 188, December 2017). A race is underway to obtain ever more rapid MA, which is jeopardising the reliable evaluation of the harm-benefit balance of drugs.
机译:对新药物的评估遵循几十年来建立的过程,鉴于许多健康灾害:临床前研究,特别是动物研究;然后在健康志愿者(I阶段)中的初步试验;然后具有非比较试验的实验阶段和有限数量的患者(II期)的第一个比较试验;最后反对参考处理或安慰剂的比较试验,旨在确认假设(III期)。在20世纪90年代,承认新药的疗效应通过至少两个对参考治疗的比较试验证明。然而,现在有多年来,市场授权(MA)经常根据单一第三阶段的比较审判,甚至是第二阶段试验而批准,就法是达拉姆巴布为多发性骨髓瘤的单一疗法(参见预定审判188 ,2017年12月)。正在进行一场比赛,以获得更多的快速MA,这是危及对药物危害效益平衡的可靠评估。

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    《Prescrire international》 |2018年第190期|共1页
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  • 正文语种 eng
  • 中图分类 药学;
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