The history of controlled clinical trials in China. Part 2: from the advent of large-scale multicentre randomised controlled trials through contemporary self-reflection.
作者信息
Yu Xuan, Chen Yaolong, Podolsky Scott H
机构信息
Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences (2021RU017), Lanzhou University School of Basic Medical Sciences, Lanzhou 730000, China.
Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.
出版信息
J R Soc Med. 2025 Jun 3:1410768251347259. doi: 10.1177/01410768251347259.
Abstract
摘要
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1
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2
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BMJ. 2022 Mar 30;376:e067476. doi: 10.1136/bmj-2021-067476.
3
Clinical Epidemiology in China series. Paper 1: Evidence-based medicine in China: An oral history study.《中国临床流行病学系列》第 1 期：中国循证医学：一项口述历史研究。
J Clin Epidemiol. 2021 Dec;140:165-171. doi: 10.1016/j.jclinepi.2021.08.012. Epub 2021 Aug 17.
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Effect of redundant clinical trials from mainland China evaluating statins in patients with coronary artery disease: cross sectional study.评价冠心病患者应用他汀类药物的中国大陆重复临床试验的影响：横断面研究。
BMJ. 2021 Feb 2;372:n48. doi: 10.1136/bmj.n48.
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6
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Trials. 2015 Jun 1;16:243. doi: 10.1186/s13063-015-0769-z.
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