Design, Conduct, and Analysis of Externally Controlled Trials
In this cross-sectional study of ECTs, current practices in the design, conduct, and analysis were suboptimal, limiting their reliability and credibility. The study identified several critical methodological issues, such as the lack of justification for using external controls, failure to prespecify external controls in the protocol, insufficient use of confounding adjustment techniques, inadequate sensitivity analyses, and almost complete absence of quantitative bias analyses. Therefore, actionable suggestions for future ECT practices are proposed.
Authors
- Jie Wan (ORCID: https://orcid.org/0000-0002-4789-6049)
- Mingqi Wang
- Xin Sun
- Xiaochao Luo (ORCID: https://orcid.org/0000-0001-9595-5659)
- Ke Deng (ORCID: https://orcid.org/0000-0002-3278-0748)
- Minghong Yao (ORCID: https://orcid.org/0000-0001-8151-6014)
- Ying Zhang (ORCID: https://orcid.org/0000-0002-9347-0225)
- Kang Zou (ORCID: https://orcid.org/0000-0002-1253-1816)
- Kangfa Deng (ORCID: https://orcid.org/0000-0002-0807-1247)
- Jiali Liu (ORCID: https://orcid.org/0000-0003-4749-3079)
- Ling Li (ORCID: https://orcid.org/0000-0001-7689-1856)
- Yanmei Liu (ORCID: https://orcid.org/0000-0003-3628-2663)
- Jiayidaer Huan
Institutions
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- West China Medical Center of Sichuan University (CN)
- Integrated Chinese Medicine (China) (HK)
- Guang’anmen Hospital (CN)
- Impact (CA)
- Chengdu University of Traditional Chinese Medicine (CN)
- McMaster University (CA)
Publication Details
- Journal
- JAMA Network Open
- Published
- 2025-09-04
- DOI
- https://doi.org/10.1001/jamanetworkopen.2025.30277
- Citations
- 2
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 5.26
Funders
- National Natural Science Foundation of China
- China Postdoctoral Science Foundation
- National Science Fund for Distinguished Young Scholars