Research and Development Costs for New Drugs by Therapeutic Category
Research and Development Costs for New Drugs by Therapeutic Category
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按治疗类别划分的新药研发成本
DOI：
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发表时间：
1995
期刊：
影响因子：
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通讯作者：
L. Lasagna
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文献类型：
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作者：
J. DiMasi;R. W. Hansen;Henry Grabowski;L. Lasagna
摘要对新化学实体（NCE）随机样本的临床期（即临床试验和长期动物试验）开发成本进行了检查，以确定平均成本的差异。所有研究的NCE都是在1970年至1982年期间首次在人类中进行测试，并根据治疗类别进行分类。不成功项目的成本包括在美国市场批准项目的成本中。包括在获得回报之前因支出资金而放弃的收入（“时间成本”），资本化每次获批NCE的临床期成本（即自付费用加时间）分别为70美元、98美元、03美元和1.63亿美元（1993年美元）。综合所有治疗类别的数据，每个批准的NCE的平均临床期成本为9300万美元。批准的NCE的平均资本化临床期成本为710万美元，（外用类固醇）至6670万美元（用于心血管药物）[ 1993年美元]。每个获批NCE的临床期总成本估计值取决于平均自付临床期成本，各阶段的损耗率（即化合物退出活性测试的比率）、上市批准和开发的概率以及监管审查时间。阶段损耗和批准率是治疗类别之间临床期总成本变化的最重要来源，按治疗类别的开发成本估计与上市第五年的美国销售额没有很强的相关性。心血管NCE的销售收入远高于平均水平，但这些药物的临床开发成本仅略高于平均水平。相反，非甾体抗炎药达到了平均销售收入，但远高于平均开发成本。
SummaryThe clinical period (i.e. clinical trial and long term animal testing) development costs of a random sample of new chemical entities (NCEs) were examined for differences in average cost. All of the NCEs studied were first tested in humans between 1970 and 1982, and were classified for the purposes of the study by therapeutic class. The costs of unsuccessful projects were included with those of projects that resulted in US marketing approval.Including income forgone from expending funds before returns are earned (‘time costs’), the capitalised (i.e. out-of-pocket plus time) clinical period costs per approved NCE were $US70, $US98, $USI03 and $US163 million (1993 dollars) for anti-infective, cardiovascular, neuropharmacological and nonsteroidal anti-inflammatory drugs, respectively. Combining the data for all therapeutic categories, the mean clinical period cost per approved NCE was $US93 million.Omitting costs associated with unsuccessful projects, the mean capitalised clinical period costs for approved NCEs ranged from $US7.1 million (for topical steroids) to $US66.7 million (for cardiovascular agents) [ 1993 dollars ].The estimates of total clinical period costs per approved NCE depend on average out-of-pocket clinical phase costs, attrition rates across phases (i.e. the rates at which compounds drop out of active testing), the probability of marketing approval and deve lopment and regulatory review times. Phase attrition and approval rates are the most imponant sources of variability in total clinical period costs between therapeutic categories.Development cost estimates by therapeutic category did not correlate strongly with US sales in the fifth year of marketing. Cardiovascular NCEs had much higher than average sales revenues but clinical development costs for these drugs were only slightly above average. Conversely, nonsteroidal anti-inflammatory drugs attained average sales revenues but had much higher than average development costs.