Dynamic clinical trial success rates for drugs in the 21st century

Ying Zhou, Yintao Zhang, Hangwei Xu, Zhen Chen, Shijie Huang, Yinghong Li, Jianbo Fu, Hongning Zhang, Donghai Zhao, Xichen Lian, Yuan Zhou, Xinyi Shen, Kaixuan Liu, Yunqing Qiu, Yanzhong Wang, Wanqing Xie, Lianyi Han, Haibin Dai and Feng Zhu ()
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Ying Zhou: Zhejiang University
Yintao Zhang: Zhejiang University
Hangwei Xu: Zhejiang University
Zhen Chen: Zhejiang University
Shijie Huang: Zhejiang University
Yinghong Li: Zhejiang University
Jianbo Fu: ETH Zurich
Hongning Zhang: Zhejiang University
Donghai Zhao: Zhejiang University
Xichen Lian: Zhejiang University
Yuan Zhou: Zhejiang University
Xinyi Shen: Yale University
Kaixuan Liu: Zhejiang University
Yunqing Qiu: Westlake University
Yanzhong Wang: King’s College London
Wanqing Xie: Anhui Medical University
Lianyi Han: Fudan University
Haibin Dai: Zhejiang University
Feng Zhu: Zhejiang University

Nature Communications, 2025, vol. 16, issue 1, 1-22

Abstract: Abstract In clinical drug development, two fundamental questions must be addressed: what is the success rate of drugs in clinical trial; how does such rate change over time. Here, a dynamic strategy for calculating clinical trial success rate (ClinSR) is proposed, which identifies that: the ClinSR has been declining since the early 21st century, yet it hits a plateau and recently starts to increase; the ClinSR for repurposed drugs is unexpectedly lower than that for all drugs in recent years; and an extremely low ClinSR is found for anti-COVID-19 drugs. In-depth analysis reports great variations among the ClinSRs of various diseases, developmental strategies, and drug modalities. A platform ClinSR.org ( https://ClinSR.org/ ), is then developed to show how ClinSRs change over time. All in all, this work enables accurate, timely and continuous assessment of ClinSRs, for now and the future, to aid pharmaceutical and economic decision making.

Date: 2025
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DOI: 10.1038/s41467-025-64552-2

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