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

Author

Listed:
  • 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)

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.

Suggested Citation

  • 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, 2025. "Dynamic clinical trial success rates for drugs in the 21st century," Nature Communications, Nature, vol. 16(1), pages 1-22, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-64552-2
    DOI: 10.1038/s41467-025-64552-2
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    References listed on IDEAS

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    1. Jeffrey L. Cummings & Yadi Zhou & Alexandra Stone & Davis Cammann & Reina Tonegawa-Kuji & Jorge Fonseca & Feixiong Cheng, 2025. "Drug repurposing for Alzheimer’s disease and other neurodegenerative disorders," Nature Communications, Nature, vol. 16(1), pages 1-10, December.
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