临床试验设计与解读中的当前问题。
Current issues in the design and interpretation of clinical trials.
作者信息
Pocock S J
出版信息
Br Med J (Clin Res Ed). 1985 Jan 5;290(6461):39-42. doi: 10.1136/bmj.290.6461.39.
Abstract
Though there have been considerable improvements in the use of statistical methods for clinical trials in recent years, there remain major practical difficulties in the design and interpretation of many trials. This paper concentrates on problems relating to randomisation, the overemphasis on significance testing, and the inadequate size of many trials. Each topic is illustrated by examples from recent trials.
摘要
尽管近年来在临床试验统计方法的应用方面有了相当大的改进，但在许多试验的设计和解释方面仍然存在重大的实际困难。本文着重探讨与随机化、对显著性检验的过度强调以及许多试验规模不足相关的问题。每个主题都通过近期试验中的实例进行说明。
相似文献
1
Current issues in the design and interpretation of clinical trials.临床试验设计与解读中的当前问题。
Br Med J (Clin Res Ed). 1985 Jan 5;290(6461):39-42. doi: 10.1136/bmj.290.6461.39.
2
A design for phase II testing of anticancer agents within a phase III clinical trial.一种在III期临床试验中进行抗癌药物II期测试的设计。
Control Clin Trials. 1988 Jun;9(2):107-18. doi: 10.1016/0197-2456(88)90032-3.
3
Patient heterogeneity in clinical trials.临床试验中的患者异质性。
Cancer Treat Rep. 1980 Feb-Mar;64(2-3):405-10.
4
Current research in statistical methodology for clinical trials.
Biometrics. 1982 Mar;38 Suppl:141-53.
5
[Methodology of controlled clinical studies on the primary treatment of operable breast cancer].[可手术乳腺癌初始治疗的对照临床研究方法学]
Strahlentherapie. 1984 Aug;160(8):459-68.
6
Commentary on the published results of the Lipid Research Clinics Coronary Primary Prevention Trial.
JAMA. 1985 Apr 12;253(14):2091-3.
7
The Coronary Drug Project. Experimental design features.冠状动脉药物项目。实验设计特点。
Control Clin Trials. 1983 Dec;4(4):313-32. doi: 10.1016/0197-2456(83)90019-3.
8
Statistical issues in the use of dynamic allocation methods for balancing baseline covariates.在使用动态分配方法平衡基线协变量时的统计问题。
Br J Cancer. 2011 May 24;104(11):1711-5. doi: 10.1038/bjc.2011.157. Epub 2011 May 3.
9
Timely topics in statistical methods for clinical trials.
Annu Rev Biophys Bioeng. 1982;11:81-104. doi: 10.1146/annurev.bb.11.060182.000501.
10
General statistical design considerations of randomized clinical trials.随机临床试验的一般统计设计考量
Prog Clin Biol Res. 1988;264:61-70.
引用本文的文献
1
Exploring the fragility of meta-analyses in ophthalmology: a systematic review.探索眼科学中荟萃分析的脆弱性：系统评价。
Eye (Lond). 2024 Nov;38(16):3153-3160. doi: 10.1038/s41433-024-03255-2. Epub 2024 Jul 20.
2
Statistical fragility of outcomes in acellular dermal matrix literature: A systematic review of randomized controlled trials.脱细胞真皮基质文献中结局的统计学脆弱性：一项随机对照试验的系统评价。
J Plast Reconstr Aesthet Surg. 2024 Apr;91:284-292. doi: 10.1016/j.bjps.2024.02.047. Epub 2024 Feb 11.
3
Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.评估 COVID-19 疫苗疗效试验的稳健性：系统评价和荟萃分析，2023 年 1 月。
Euro Surveill. 2023 Jun;28(22). doi: 10.2807/1560-7917.ES.2023.28.22.2200706.
4
The fragility of statistical significance in distal femur fractures: systematic review of randomized controlled trials.远端股骨骨折中统计显著性的脆弱性：随机对照试验的系统评价。
Eur J Orthop Surg Traumatol. 2023 Aug;33(6):2411-2418. doi: 10.1007/s00590-022-03452-3. Epub 2022 Dec 3.
5
Comparative Studies in the Shoulder Literature Lack Statistical Robustness: A Fragility Analysis.肩部文献中的比较研究缺乏统计稳健性：一项脆弱性分析。
Arthrosc Sports Med Rehabil. 2021 Oct 12;3(6):e1899-e1904. doi: 10.1016/j.asmr.2021.08.017. eCollection 2021 Dec.
6
The Fragility of Significance in the Hip Arthroscopy Literature: A Systematic Review.髋关节镜文献中意义的脆弱性：一项系统综述
JB JS Open Access. 2021 Oct 21;6(4). doi: 10.2106/JBJS.OA.21.00035. eCollection 2021 Oct-Dec.
7
The Fragility of Statistical Findings in Achilles Tendon Injury Research: A Systematic Review.跟腱损伤研究中统计结果的脆弱性：系统评价。
J Am Acad Orthop Surg Glob Res Rev. 2021 Sep 2;5(9):e21.00018. doi: 10.5435/JAAOSGlobal-D-21-00018.
8
An interactive retrieval system for clinical trial studies with context-dependent protocol elements.具有上下文相关协议元素的临床试验研究的交互式检索系统。
PLoS One. 2020 Sep 18;15(9):e0238290. doi: 10.1371/journal.pone.0238290. eCollection 2020.
9
Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study).成人肥胖症的社会促进维持治疗：一项随机对照可行性研究的研究方案（SFM研究）
BMJ Open. 2016 Aug 31;6(8):e010845. doi: 10.1136/bmjopen-2015-010845.
10
When should we change our clinical practice based on the results of a clinical study? The hierarchy of evidence.我们应该在何时根据临床研究结果改变临床实践？证据的等级体系。
Intern Emerg Med. 2015 Sep;10(6):745-7. doi: 10.1007/s11739-015-1230-8. Epub 2015 Apr 10.
本文引用的文献
1
Medical Research Council Vitamin Study.医学研究委员会维生素研究
Lancet. 1984 Jun 9;1(8389):1308.
2
Practical experience of randomization in cancer trials: an international survey.癌症试验随机化的实践经验：一项国际调查。
Br J Cancer. 1982 Sep;46(3):368-75. doi: 10.1038/bjc.1982.212.
3
Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors.
J Clin Oncol. 1983 Feb;1(2):164-9. doi: 10.1200/JCO.1983.1.2.164.
4
Effect of diet and smoking intervention on the incidence of coronary heart disease. Report from the Oslo Study Group of a randomised trial in healthy men.饮食与吸烟干预对冠心病发病率的影响。奥斯陆健康男性随机试验研究小组的报告。
Lancet. 1981 Dec 12;2(8259):1303-10. doi: 10.1016/s0140-6736(81)91338-6.
5
D-penicillamine treatment improves survival in primary biliary cirrhosis.青霉胺治疗可提高原发性胆汁性肝硬化患者的生存率。
Lancet. 1981 Jun 13;1(8233):1275-7. doi: 10.1016/s0140-6736(81)92456-9.
6
Possible prevention of neural-tube defects by periconceptional vitamin supplementation.孕前补充维生素可能预防神经管缺陷。
Lancet. 1980 Feb 16;1(8164):339-40. doi: 10.1016/s0140-6736(80)90886-7.
7
Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design.需要对每位患者进行长期观察的随机临床试验的设计与分析。I. 引言与设计。
Br J Cancer. 1976 Dec;34(6):585-612. doi: 10.1038/bjc.1976.220.
8
Restricted randomization designs in clinical trials.临床试验中的受限随机化设计。
Biometrics. 1979 Jun;35(2):503-12.
9
Allocation of patients to treatment groups in a controlled clinical study.在对照临床研究中患者被分配至治疗组的情况。
Br J Cancer. 1978 May;37(5):849-57. doi: 10.1038/bjc.1978.124.
Zotero 插件