Diagnosing the decline in pharmaceutical R&D efficiency

Diagnosing the decline in pharmaceutical R&D efficiency
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DOI:
10.1038/nrd3681
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发表时间:
2012-03-01
影响因子:
120.1
通讯作者:
Warrington, Brian
Warrington, Brian
中科院分区:
医学1区
文献类型:
--
作者:
Scannell, Jack W.;Blanckley, Alex;Warrington, Brian

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在过去的60年里,许多科学、技术和管理因素都取得了巨大进步,这些因素应该有助于提高商业药物研究和开发的效率。然而,自1950年以来,每10亿美元研发资金中批准的新药数量大约每9年减少一半,经通胀调整后下降约80倍。针对研发效率下降的问题,提出了许多解决方案。然而,迄今为止它们显然缺乏影响力,而且就新药数量而言,投入增加与产出下降之间的反差使人们有理由问,潜在的问题是否得到了正确的诊断。在这里,我们讨论了四个因素,我们认为是主要原因,我们称之为“比披头士乐队更好”的问题;“谨慎的监管”的问题;“扔钱在它”的倾向;和“基础研究蛮力”的偏见。我们的目标是对R&D效率下降的原因进行更系统的分析。
The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. There have been many proposed solutions to the problem of declining R&D efficiency. However, their apparent lack of impact so far and the contrast between improving inputs and declining output in terms of the number of new drugs make it sensible to ask whether the underlying problems have been correctly diagnosed. Here, we discuss four factors that we consider to be primary causes, which we call the 'better than the Beatles' problem; the 'cautious regulator' problem; the 'throw money at it' tendency; and the 'basic research-brute force' bias. Our aim is to provoke a more systematic analysis of the causes of the decline in R&D efficiency.