领先制药公司研发成功率标杆化：2006-2022年FDA批准的实证分析。

IF 6.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2025-01-11 DOI:10.1016/j.drudis.2025.104291

Alexander Schuhmacher, Markus Hinder, Elazar Brief, Oliver Gassmann, Dominik Hartl

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引用次数: 0

摘要

以往的分析提供了临床开发成功率约10%的行业基准。然而，先前的分析受到时间范围狭窄、研究焦点多样化、阶段到阶段转换方法的偏差或对特定用例的关注的限制。我们利用clinicaltrials.gov网站上的数据，计算了无偏输入：输出比（I期和FDA新药批准），分析了首次批准的可能性，这些数据包括总共2092种有效成分、18家领先制药公司（2006-2022年）进行的19927项临床试验和274种新药批准。我们的研究显示，领先的研究型制药公司的平均首次批准率为14.3%，范围从8%到23%不等。

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Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006-2022).

Previous analyses provide an industry benchmark of ∼10% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.gov, encompassing a total of 2092 active ingredients, 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006-2022) and 274 new drug approvals. Our study reveals an average likelihood of first approval rate of 14.3% across leading research-based pharmaceutical companies, broadly ranging from 8% to 23%.

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来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.