Dynamic clinical trial success rates for drugs in the 21st century
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.
Authors
- Ying Zhou (ORCID: https://orcid.org/0000-0002-5666-6405)
- Jianbo Fu (ORCID: https://orcid.org/0000-0003-3358-8106)
- Yunqing Qiu
- Hongning Zhang (ORCID: https://orcid.org/0000-0002-7818-7915)
- Lianyi Han (ORCID: https://orcid.org/0000-0002-6364-7843)
- Xinyi Shen (ORCID: https://orcid.org/0000-0001-6519-9311)
- Yinghong Li (ORCID: https://orcid.org/0000-0003-3629-519X)
- Yintao Zhang (ORCID: https://orcid.org/0000-0002-5263-3438)
- Yuan Zhou (ORCID: https://orcid.org/0000-0003-2892-0100)
- Xichen Lian
- Haibin Dai (ORCID: https://orcid.org/0000-0002-5768-2714)
- Yanzhong Wang (ORCID: https://orcid.org/0000-0002-0768-1676)
- Hangwei Xu
- Feng Zhu (ORCID: https://orcid.org/0000-0001-8069-0053)
- Zhen Chen (ORCID: https://orcid.org/0000-0001-6789-6188)
- Shijie Huang (ORCID: https://orcid.org/0000-0001-6755-4735)
- Kaixuan Liu (ORCID: https://orcid.org/0000-0003-1207-3621)
- Donghai Zhao
- Wanqing Xie
Institutions
- King's College London (GB)
- Anhui Medical University (CN)
- Fudan University (CN)
- Westlake University (CN)
- Yale University (US)
- ETH Zurich (CH)
- Second Affiliated Hospital of Zhejiang University (CN)
- Huashan Hospital (CN)
- Zhejiang University (CN)
Publication Details
- Journal
- Nature Communications
- Published
- 2025-10-29
- DOI
- https://doi.org/10.1038/s41467-025-64552-2
- Citations
- 4
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 10.52
Funders
- Zhejiang University