Design, Conduct, and Analysis of Externally Controlled Trials

How are externally controlled trials (ECTs) currently designed, conducted, and analyzed in practice, and do they use methods, such as statistical methods, to control bias?In this cross-sectional analysis of 180 ECTs published between 2010 and 2023, several critical methodological issues were identified, and actionable recommendations were proposed to support improvements in future ECT practices.These findings emphasize the need for researchers to improve ECT practices and highlight the urgent need for collaboration among researchers, regulators, and journal editors to develop standardized methodological and reporting guideline for ECTs.

Corresponding Authors: Xin Sun, PhD (sunxin@wchscu.cn), and Ling Li, PhD (liling@wchscu.cn), Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center and Cochrane China, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu 610041, Sichuan, China.

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