Noninferiority trials: clinical understandings and misunderstandings.
作者信息
Powers John H, Fleming Thomas R
机构信息
SAIC in support of the Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), 6700B Rockledge Drive, Room 1123, Bethesda, MD 20892, USA.
Department of Biostatistics, University of Washington, Box 357232, Seattle, WA, USA.
出版信息
Clin Investig (Lond). 2013 Mar 1;3(3):215-218. doi: 10.4155/cli.12.157.
Abstract
摘要
相似文献
1
Noninferiority trials: clinical understandings and misunderstandings.非劣效性试验：临床理解与误解
Clin Investig (Lond). 2013 Mar 1;3(3):215-218. doi: 10.4155/cli.12.157.
2
Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.1991年至2011年抗生素随机临床试验中研究目的的知情同意书
JAMA Intern Med. 2017 Oct 1;177(10):1452-1459. doi: 10.1001/jamainternmed.2017.3820.
3
Choice of delta noninferiority margin and dependency of the noninferiority trials.δ非劣效界值的选择及非劣效性试验的依赖性
J Biopharm Stat. 2007;17(2):279-88. doi: 10.1080/10543400601177384.
4
Defining the noninferiority margin and analysing noninferiority: An overview.定义非劣效性界值并分析非劣效性：概述。
Br J Clin Pharmacol. 2017 Aug;83(8):1636-1642. doi: 10.1111/bcp.13280. Epub 2017 Apr 6.
5
Consensus on Language for Advance Informed Consent in Health Care-Associated Pneumonia Clinical Trials Using a Delphi Process.采用德尔菲法达成医疗相关性肺炎临床试验中预先知情同意书语言的共识
JAMA Netw Open. 2020 May 1;3(5):e205435. doi: 10.1001/jamanetworkopen.2020.5435.
6
Consequences of Inaccurate Assumptions in Coronary Stent Noninferiority Trials: A Systematic Review and Meta-analysis.冠状动脉支架非劣效性试验中不准确假设的后果：系统评价和荟萃分析。
JAMA Cardiol. 2022 Mar 1;7(3):320-327. doi: 10.1001/jamacardio.2021.5724.
7
Mixed noninferiority margin and statistical tests in active controlled trials.活性对照试验中的混合非劣效性界值与统计检验。
J Biopharm Stat. 2007;17(2):339-57. doi: 10.1080/10543400601183861.
8
Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate.使用单一的非劣效性边界或保留分数来涵盖整个药理学类别被认为是不恰当的。
J Clin Epidemiol. 2018 Dec;104:15-23. doi: 10.1016/j.jclinepi.2018.07.004. Epub 2018 Aug 25.
9
Multiple testing of noninferiority hypotheses in active controlled trials.活性对照试验中非劣效性假设的多重检验。
J Biopharm Stat. 2004 May;14(2):327-35. doi: 10.1081/BIP-120037183.
10
Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study.肿瘤学非劣效性和等效性试验的理由、边缘值及分析人群：一项元流行病学研究
J Natl Cancer Inst. 2025 May 1;117(5):898-906. doi: 10.1093/jnci/djae318.
引用本文的文献
1
Why too much biomedical research is often undeserving of the public's trust.为何太多的生物医学研究往往辜负公众的信任。
Front Genet. 2025 Jun 26;16:1587616. doi: 10.3389/fgene.2025.1587616. eCollection 2025.
2
Technology-assisted cognitive-behavioral therapy for perinatal depression delivered by lived-experience peers: a cluster-randomized noninferiority trial.由有亲身经历的同伴提供的围产期抑郁症的技术辅助认知行为疗法：一项整群随机非劣效性试验。
Nat Med. 2025 Apr 8. doi: 10.1038/s41591-025-03655-1.
3
Interpreting the results of noninferiority trials-a review.非劣效性试验结果解读——综述
Br J Cancer. 2022 Nov;127(10):1755-1759. doi: 10.1038/s41416-022-01937-w. Epub 2022 Sep 15.
4
Non-inferiority Trial Investigating the Efficacy of Non-steroidal Anti-inflammatory Drugs and Antimicrobial Treatment of Mild to Moderate Clinical Mastitis in Dairy Cows With Long-lasting Udder Diseases.非劣效性试验：探究非甾体抗炎药与抗菌药物联合治疗患有持久性乳房疾病的奶牛轻至中度临床型乳房炎的疗效
Front Vet Sci. 2021 May 20;8:660804. doi: 10.3389/fvets.2021.660804. eCollection 2021.
5
Videoconferencing Psychotherapy for Panic Disorder and Agoraphobia: Outcome and Treatment Processes From a Non-randomized Non-inferiority Trial.惊恐障碍和广场恐惧症的视频会议心理治疗：非随机非劣效性试验的结果与治疗过程
Front Psychol. 2020 Aug 21;11:2164. doi: 10.3389/fpsyg.2020.02164. eCollection 2020.
6
Antimicrobial Treatment Duration in Sepsis and Serious Infections.脓毒症和严重感染的抗菌治疗持续时间。
J Infect Dis. 2020 Jul 21;222(Suppl 2):S142-S155. doi: 10.1093/infdis/jiaa247.
7
Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations.慢性疼痛临床试验结果的解读：IMMPACT推荐的考量因素
Pain. 2020 Nov;161(11):2446-2461. doi: 10.1097/j.pain.0000000000001952.
8
Designing development programs for non-traditional antibacterial agents.设计非传统抗菌药物的开发项目。
Nat Commun. 2019 Jul 31;10(1):3416. doi: 10.1038/s41467-019-11303-9.
本文引用的文献
1
Some essential considerations in the design and conduct of non-inferiority trials.非劣效性试验设计和实施中的一些基本考虑。
Clin Trials. 2011 Aug;8(4):432-9. doi: 10.1177/1740774511410994.
2
Issues in noninferiority trials: the evidence in community-acquired pneumonia.非劣效性试验中的问题：社区获得性肺炎的证据
Clin Infect Dis. 2008 Dec 1;47 Suppl 3(Suppl 3):S108-20. doi: 10.1086/591390.
3
Noninferiority and equivalence trials: deciphering 'similarity' of medical interventions.非劣效性试验和等效性试验：解读医学干预措施的“相似性”
Stat Med. 2008 Feb 10;27(3):343-52. doi: 10.1002/sim.3138.
4
Non-inferiority trials are unethical because they disregard patients' interests.非劣效性试验是不道德的，因为它们无视患者的利益。
Lancet. 2007 Dec 1;370(9602):1875-7. doi: 10.1016/S0140-6736(07)61604-3. Epub 2007 Oct 23.
5
Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials.基于非劣效性试验的新疗法的疗效维持与监管批准。
Stat Med. 2008 Feb 10;27(3):382-91. doi: 10.1002/sim.3073.
6
Current issues in non-inferiority trials.非劣效性试验中的当前问题。
Stat Med. 2008 Feb 10;27(3):317-32. doi: 10.1002/sim.2855.
7
Good enough: a primer on the analysis and interpretation of noninferiority trials.足够好：非劣效性试验的分析与解读入门
Ann Intern Med. 2006 Jul 4;145(1):62-9. doi: 10.7326/0003-4819-145-1-200607040-00011.
8
Quality of reporting of noninferiority and equivalence randomized trials.非劣效性和等效性随机试验的报告质量
JAMA. 2006 Mar 8;295(10):1147-51. doi: 10.1001/jama.295.10.1147.
9
Some fundamental issues with non-inferiority testing in active controlled trials.活性对照试验中非劣效性检验的一些基本问题。
Stat Med. 2003 Jan 30;22(2):213-25. doi: 10.1002/sim.1315.
10
International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.国际协调会议；临床试验中对照组的选择及相关问题；可及性。通知。
Fed Regist. 2001 May 14;66(93):24390-1.
Zotero 插件