The history of controlled clinical trials in China. Part 1: from the advent of clinical trials through the conduct of single-centre or small-sample RCTs
Restricted accessResearch articleFirst published online July, 2025
The history of controlled clinical trials in China. Part 1: from the advent of clinical trials through the conduct of single-centre or small-sample RCTs
BothwellLEGreeneJAPodolskySHJonesDS.Assessing the gold standard – lessons from the history of RCTs. N Engl J Med2016;
374: 2175–2181.
2.
MarksHM.The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990, 1997.
Cambridge:
Cambridge University Press.
3.
CookDJGuyattGHLaupacisASackettDL.Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest1992;
102: 305S–11S.
4.
DalyJ.Evidence-Based Medicine and the Search for a Science of Clinical Care.
Oakland:
University of California Press, 2005.
5.
BothwellLEKuoWHJonesDSPodolskySH.Social and scientific history of randomized controlled trials. In: PiantadosiSMeinertC, eds. Principles and Practice of Clinical Trials.
Cham:
Springer, 2020: 3–19.
6.
ChalmersIDukanEPodolskySDavey SmithG.The advent of fair treatment allocation schedules in clinical trials during the 19th and early 20th centuries. J R Soc Med2012;
105: 221–227.
7.
LiBYanYLvMZhaoGLiZFengS.Clinical epidemiology in China series. Paper 1: evidence-based medicine in China: an oral history study. J Clin Epidemiol2021;
140: 165–171.
8.
LiYSunXWangL.Evidence-based medicine in China. Value Health2008;
11: S156–S158.
9.
TangJZhanSErnstE.Review of randomised controlled trials of traditional Chinese medicine. BMJ1999;
319: 160–161.
10.
TianGZhaoCZhangXMuWJiangYWeiX.Evidence-based traditional Chinese medicine research: two decades of development, its impact, and breakthrough. J Evidence-Based Med2021;
14: 65–74.
11.
SeniorK.Unique, multilingual resource on testing health-care treatments. Bull World Health Org2009;
87: 412–413.
12.
GluudCWangJ.History of evidence-based medicine. In: WangJGluudC, eds. Evidence-Based Medicine and Clinical Practice.
Beijing:
Beijing Science Publisher, 2002:2–4.
13.
BlakeHA. Colonial reports
– miscellaneous. No. 25. Hong Kong. Bubonic plague. Memorandum on the treatment of patients in their own homes and in local hospitals, 1904.
14.
LeiSH.Neither Donkey nor Horse.
Chicago:
University of Chicago Press, 2014.
15.
XieZLiN.Methodological analysis of clinical articles on therapy evaluation published in Chinese Journal of Integrated Traditional & Western Medicine (in Chinese) 1982–1994. Chin J Integr Trad Western Med1995;
1: 301–306.
16.
DingMWeiMHeC.Clinical trials and clinical trial unit. Chin J Clin Rehabil2003;
7: 355–358. [丁明甫,卫茂玲,何成奇(2003). 临床试验与临床试验中心.中国临床康复 7(3): 355–358.]
17.
History of Clinical Trials in China. World Latest Medicine Information 2002; 3: 184. [中国临床实验历史 (2002). 世界最新医学信息文摘 3: 184.]
18.
LiuJ.Clinical trials and clinical trial unit. Chin J Evidence-Based Med2001;
1: 202–204. [刘建平(2001). 临床试验与临床试验中心(CTU). 中国循证医学 1(4): 202–204.]
19.
LiuJ.Clinical trials and clinical trial unit. Chin J Integr Trad Western Med2002;
22: 307–308. [刘建平. 临床试验与临床试验中心(2002). 中国中西医结合杂志 22(4): 307–308.]
ZhouXHuangfuMWeiMZhouXYuJ.
Clinical observation of furapromidium in the treatment of acute schistosomiasis in children. Natl Med J China1965;
51: 433–436. [周学章,皇甫铭,魏曼华,等 (1965). 呋喃丙胺治疗儿童急性血吸虫病的临床观察. 中华医学杂志 51(7): 433–436.]
23.
ZhouXHuangfuMZhouXWeiMChenSFanY, et al.
A comparative observation on the treatment of acute schistosomiasis with furapromidium combined with adrenocortical hormones and antimony compounds (abstract). Chin J Int Med1965;
13: 209. [周学章,皇甫铭,周晓兰,等(1965). 呋喃丙胺与肾上腺皮质激素合并锑剂治疗急性血吸虫病的比较观察(摘要).中华内科杂志 13(3): 209.]
WangSChuYZhangZ, Jiang Y and Yang D.
Comparison of the efficacy of different medication regimens for the initial treatment of pulmonary tuberculosis. Chin J Antitubercul1963;
4: 227–233.[汪士,諸云程,張振朝,等 (1963). 肺結核病初次治疗不同用药方法的疗效比較.中国防痨杂志 4: 227–233.]
26.
TianLZhangLWangN, Zhang H, Cao Y, AL, et al.
A retrospective and prospective review of the development of medical research institutions in China over the 60 years since the establishment of the nation. J Med Res2010;
39: 122–125. [田玲,张黎黎,汪楠,等 (2010). 建国60年我国医学科研机构发展回顾与展望. 医学研究杂志 2010; 39(2): 122–125.]
27.
YinY.A retrospective on the academic journal industry in the 60 years of new China. J Sichuan Univ Sci Eng (Soc Sci Ed)2012;
27: 32–39. [尹玉吉 (2012). 新中国60年学术期刊事业回眸. 四川理工学院学报(社会科学版) 27(4): 32–39.]
28.
LuoD.The flourishing development of clinical epidemiology in China. Natl Med J China1991;
71: 114. [罗德诚 (1991). 我国临床流行病学的蓬勃发展. 中华医学杂志 71(2): 114.]
29.
WangSJiBAiGZhangC.Clinical research methods (part 1). Clin Med China1987;
3: 193–196. [王树岐,纪宝华,艾刚阳,等 (1987). 临床研究方法(一). 临床医学杂志 3(4): 193–196.]
30.
ChenKQianZZhangWGuan W, Hao X, Chen Xet al.
The therapeutic effect of purified coronary heart II tablets on 112 cases of angina pectoris by double blind method. Chin J Cardiol1982;
10: 85–89. [陈可冀,钱振淮,张问渠,等(1982). 精制冠心片双盲法治疗冠心病心绞痛112例疗效分析. 中华心血管病杂志 10(2): 85–89.]
31.
LinG.Overview of the development of clinical epidemiology in China. Chin J Neurol1998;
78: 876–877. [林果为(1998). 我国临床流行病学发展简况. 中华神经科杂志 78(11): 876–877.]
32.
ZhouH.How to evaluate drug clinical trial reports. Chin J Clin Pharmacol1985;
1: 264–267. [周宏灏 (1985). 如何评价药物临床试验报告. 中国临床药理学杂志 1(4): 264–267.]
LuoHShuLFangMFang Y, Zhou D, Jia Yet al.
Analysis of the therapeutic efficacy of double-blind controlled electroacupuncture and amitriptyline in the treatment of depression. Chin J Neurol1985;
18: 273. [罗和春,舒良,方明昭,等 (1985). 双盲对照电针与阿咪替林治疗抑郁症疗效分析. 中华神经精神科杂志 18(5): 273.]
35.
WuDLiuX.David Sackett: a pioneer of evidence-based medicine. Med J Peking Union Medical College Hosp2020;
11: 449–452. [吴东,刘晓清 (2020). David Sackett:循证医学之父. 协和医学杂志 11(4): 449–452.
36.
WangWLiuLTaoSGongL and WuN, et al.
Quality of clinical trials of Chinese herbal drugs – a review of 314 published papers. Chin J Integr Trad Western Med1994;
14: 50–52 + 6. [俞国培,高思维,李怡,等 (1994). 中药临床治疗试验质量的调查——314篇文献评阅结果. 中国中西医结合杂志 14(1): 50–2 + 6.]
37.
WangQZhangB.Research design and statistical methods in Chinese medical journals. JAMA1998;
280: 283–285.
38.
SuD.Collected papers of Professor Delong Su.
Tianjin:
Tianjin Science and Technology Press, 1995:122. [苏德隆 (1995). 苏德隆教授论文选集. 天津科学技术出版社 122.]