[1]GREENE C J,MORLAND L A,DURKALSKI V L,et al. Noninferiority and equivalence designs:issues and implications for mental health research[J]. J Trauma Stress,2008,21(5):433-439.
[2]MAURI L,D'AGOSTINO R B. Challenges in the design and interpretation of noninferiority trials[J]. N Engl J Med,2017,377(14):1357-1367.
[3]SPŁAWIŃSKI J,KUŹNIAR J. Clinical trials:active control vs placebo--what is ethical?[J]. Sci Eng Ethics,2004,10(1):73-79.
[4]HILLS R K. Non-inferiority trials:No better? No worse? No change? No pain?[J]. Br J Haematol,2017,176(6):883-887.
[5]DUNNETT C W,GENT M. Significance testing to establish equivalence between treatments,with special reference to data in the form of 2×2 tables[J]. Biometrics,1977,33(4):593-602.
[6]李新旭,周军,王骏,等. 非劣效临床试验的总结与思考[J]. 中国新药杂志,2020,29(13):1469-1477.
[7]左晓春. 临床试验中采用非劣效设计应该关注的问题[J]. 中国新药杂志,2007,16(9):3.
[8]CCTS工作小组,夏结来. 非劣效临床试验的统计学考虑[J]. 中国卫生统计,2012,29(2):270-274.
[9]U. S. Department of Health and Human Services Food and Drug Administration. Non-inferiority clinical trials to establish effectiveness guidance for industry[EB/OL].(2016-11-01)[2023-04-30]. https://www.fda.gov/media/78504/download.
[10]The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Choice of control group and related issues in clinical trials E10 [EB/OL].(2000-07-20)[2023-04-30]. https://database.ich.org/sites/default/files/E10_Guideline.pdf.
[11]杨进波,赵德恒,赵明,等. 美国FDA对抗菌药物临床试验非劣效设计的考虑[J]. 中国临床药理学杂志,2008,24(3):2.
[12]刘玉秀,姚晨,陈峰,等. 非劣性/等效性试验的样本含量估计及把握度分析[J]. 中国卫生统计,2004,21(1):31-35.
[13]胡国清,黄琼峰,黄镇南,等. 临床研究中最小临床意义变化值确定方法[J]. 中南大学学报(医学版),2009,34(11):1058-1062.
[14]ALTHUNIAN T A,DE BOER A,GROENWOLD R H H,et al. Defining the noninferiority margin and analysing noninferiority:an overview [J]. Br J Clin Pharmacol,2017,83(8):1636-1642.
[15]高晨燕,冯毅,陈峰,等. 临床试验的统计学指导原则(1)[J]. 中国临床药理学杂志,1999,15(3):8.
[16]陈阳,刘媛媛,李长平,等. 如何正确运用t检验——两算术均值比较非劣效性t检验及SAS实现[J]. 四川精神卫生,2020,33(3):226-230.
[17] PIAGGIO G,ELBOURNE D R,ALTMAN D G,et al. Reporting of noninferiority and equivalence randomized trials[J]. JAMA,2012,308(24):2594-2604.
[18]曾琳,刘小莉,赵一鸣. 非劣效临床试验中生物爬行现象[J]. 中华儿科杂志,2020,58(12):1028.
[19]WANG Y J,LI S Y,PAN Y S,et al. Tenecteplase versus alteplase in acute ischaemic cerebrovascular events(TRACE-2):a phase 3,multicentre,open-label,randomised controlled,non-inferiority trial[J]. Lancet,2023,401(10377):645-654.
[20]PAN Y S,MENG X,YUAN B S,et al. Indobufen versus aspirin in patients with acute ischaemic stroke in China(INSURE):a randomised,double-blind,double-dummy,active control,non-inferiority trial[J]. Lancet Neurol,2023,22(6):485-493.