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随机对照试验 (查看源代码)

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“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。<ref name="Ranjith-2005">{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = Psychother Psychosom | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 ~~| s2cid = 143644933~~ }}</ref>科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。<ref name="Peto-1976">{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = Br J Cancer | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}</ref><ref name="Peto-1977">{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = Br J Cancer | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}</ref>并非所有的随机临床试验都是随机对照试验（其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的）。随机对照临床试验这个术语是临床研究中使用的另一个术语；<ref name="Wollert-2004">{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = The Lancet | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 ~~| s2cid = 24361586~~ }}</ref>然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。

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“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。<ref name="Ranjith-2005">{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = Psychother Psychosom | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 }}</ref>科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。<ref name="Peto-1976">{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = Br J Cancer | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}</ref><ref name="Peto-1977">{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = Br J Cancer | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}</ref>并非所有的随机临床试验都是随机对照试验（其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的）。随机对照临床试验这个术语是临床研究中使用的另一个术语；<ref name="Wollert-2004">{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = The Lancet | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 }}</ref>然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。

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{{cite journal|last=Daston|first=Lorraine | name-list-style = vanc |title=Scientific Error and the Ethos of Belief|journal=Social Research|volume=72|number=1|year=2005|page=18}}</ref>1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。<ref name="pmid16992882">{{cite journal | vauthors = Rivers WH, Webber HN | title = The action of caffeine on the capacity for muscular work | journal = The Journal of Physiology | volume = 36 | issue = 1 | pages = 33–47 | date = August 1907 | pmid = 16992882 | pmc = 1533733 | doi = 10.1113/jphysiol.1907.sp001215 }}</ref>

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在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<ref>{{cite journal| author=Charles Sanders Peirce and Joseph Jastrow|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm</ref>和教育学<ref>{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=Isis (journal)|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489~~|s2cid=52201011~~}}</ref><ref>{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70~~|s2cid=143685203~~|author-link=Stephen M. Stigler}}</ref><ref>{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=Isis (journal)|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574~~|s2cid=23526321~~|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。

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在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<ref>{{cite journal| author=Charles Sanders Peirce and Joseph Jastrow|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm</ref>和教育学<ref>{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=Isis (journal)|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489}}</ref><ref>{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|author-link=Stephen M. Stigler}}</ref><ref>{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=Isis (journal)|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。

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=== 试验注册 ===

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2004年，医学杂志编辑国际委员会（ICMJE）宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。<ref name="pmid15356289">{{cite journal |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}</ref>尽管如此，试验登记可能仍然延迟或根本不会发生。<ref name="pmid22147862">{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862 | doi-access=free }}</ref><ref name="pmid19724045">{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045 | doi-access=free }}</ref>医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。<ref>{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2~~|s2cid=40317464~~}}</ref>

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2004年，医学杂志编辑国际委员会（ICMJE）宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。<ref name="pmid15356289">{{cite journal |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}</ref>尽管如此，试验登记可能仍然延迟或根本不会发生。<ref name="pmid22147862">{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862 | doi-access=free }}</ref><ref name="pmid19724045">{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045 | doi-access=free }}</ref>医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。<ref>{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2}}</ref>

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== 随机化 ==

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随机对照试验中适当随机化的优点包括：<ref name="SchulzGrimes2002">{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 ~~| s2cid = 291300~~ }}</ref>

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随机对照试验中适当随机化的优点包括：<ref name="SchulzGrimes2002">{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 }}</ref>

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=== 分配隐藏 ===

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“分配隐藏”（定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”）在随机对照试验中很重要。.<ref name="Forder-2005">{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x ~~| s2cid = 202149~~ }}</ref>在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。<ref name="Schulz-2002">{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA ~~| s2cid = 12902486~~ }}</ref>这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。<ref name="Schulz-2002"/>一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。

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“分配隐藏”（定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”）在随机对照试验中很重要。.<ref name="Forder-2005">{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x }}</ref>在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。<ref name="Schulz-2002">{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA }}</ref>这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。<ref name="Schulz-2002"/>一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。

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传统上，盲法随机对照试验分为“单盲”、“双盲”或“三盲”；然而，2001年和2006年的两项研究表明，这些术语对不同的人有不同的含义。<ref name="Devereaux-2001">{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = J Am Med Assoc | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi = 10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}</ref><ref name="Haahr-2006">{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 ~~| s2cid = 23818514~~ }}</ref>2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成，干预分配后谁被“蒙面”了（例如，参与者、护理提供者、评估结果的人员）以及其原因”。<ref name="Moher-2010"/>

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传统上，盲法随机对照试验分为“单盲”、“双盲”或“三盲”；然而，2001年和2006年的两项研究表明，这些术语对不同的人有不同的含义。<ref name="Devereaux-2001">{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = J Am Med Assoc | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi = 10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}</ref><ref name="Haahr-2006">{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 }}</ref>2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成，干预分配后谁被“蒙面”了（例如，参与者、护理提供者、评估结果的人员）以及其原因”。<ref name="Moher-2010"/>

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没有盲法的随机对照试验被称为“未盲法”，<ref name="Marson-2007">{{Cite journal |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = The Lancet|| volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}</ref>也称“开放”，<ref name="Chan-1995">{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = BMJ | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}</ref>或者（如果干预是一种药物）“开放标签”。<ref name="Fukase-2008">{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 ~~| s2cid = 13741892~~ | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}</ref>2008年的一项研究得出结论，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；<ref name="Wood-2008"/>例如，在RCT多发性硬化症的治疗中，未盲的神经学家认为治疗是有益的。<ref name="Noseworthy-1994">{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16~~| s2cid=2663997~~}}</ref>在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”。<ref name="Zwarenstein-2008"/>

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没有盲法的随机对照试验被称为“未盲法”，<ref name="Marson-2007">{{Cite journal |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = The Lancet|| volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}</ref>也称“开放”，<ref name="Chan-1995">{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = BMJ | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}</ref>或者（如果干预是一种药物）“开放标签”。<ref name="Fukase-2008">{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}</ref>2008年的一项研究得出结论，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；<ref name="Wood-2008"/>例如，在RCT多发性硬化症的治疗中，未盲的神经学家认为治疗是有益的。<ref name="Noseworthy-1994">{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16}}</ref>在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”。<ref name="Zwarenstein-2008"/>

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随机对照试验中使用的统计方法类型取决于数据的特征，包括：

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* 对于二元结果数据，可以使用逻辑回归（例如，预测接受聚乙二醇干扰素α-2a治疗丙型肝炎后的持续病毒学应答<ref name="Manns-2001">{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 ~~| s2cid = 14583372~~ }}</ref>）和其他方法。

+

* 对于二元结果数据，可以使用逻辑回归（例如，预测接受聚乙二醇干扰素α-2a治疗丙型肝炎后的持续病毒学应答<ref name="Manns-2001">{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 }}</ref>）和其他方法。

* 对于连续的结果数据，协方差分析（例如，急性冠状动脉综合征后接受阿托伐他汀后血脂水平的变化<ref name="Schwartz-2001">{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = J Am Med Assoc | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}</ref>）可以用于检测预测变量效果。

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* 对于可能删失的时间到事件结果数据，生存分析（如绝经后接受激素替代治疗后冠心病发生时间的卡普兰-迈耶估计值 Kaplan–Meier estimator和考克斯比例风险模型 Cox proportional hazards model<ref name="Rossouw-2002">{{Cite journal | author = Rossouw JE, Anderson GL, Ross Prentice, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = J Am Med Assoc | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 ~~| s2cid = 20149703~~ | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}</ref>）是合适的。

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* 对于可能删失的时间到事件结果数据，生存分析（如绝经后接受激素替代治疗后冠心病发生时间的卡普兰-迈耶估计值 Kaplan–Meier estimator和考克斯比例风险模型 Cox proportional hazards model<ref name="Rossouw-2002">{{Cite journal | author = Rossouw JE, Anderson GL, Ross Prentice, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = J Am Med Assoc | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 |url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}</ref>）是合适的。

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* 美国食品药品监督管理局批准后，抗心律失常药氟卡尼和恩卡尼分别于1986年和1987年上市。<ref name="Anderson-1997">{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting "Deadly Medicine" to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}</ref>关于这些药物的非随机研究被描述为“glowing”，1989年初，<ref name="Rubin-2006">{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}</ref>它们的销售额增加到每月总计约165，000张处方。然而，在那一年，一份RCT的初步报告得出结论，这两种药物会增加死亡率。<ref name="CAST-1989">{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}</ref>这些药物的销量随后下降。<ref name="Anderson-1997"/>

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* 在2002年之前，<ref name="Rubin-2006"/>基于观察性研究，医生为绝经后妇女开激素替代疗法以预防心肌梗死是常规。然而，在2002年和2004年，妇女健康倡议发表的随机对照试验声称，服用雌激素加孕激素的激素替代疗法的妇女比服用安慰剂的妇女心肌梗死的发生率更高，并且仅服用雌激素的激素替代疗法不会降低冠心病的发病率。<ref name="Rossouw-2002"/><ref name="Anderson-2004">{{Cite journal |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}</ref>观察性研究和随机对照试验之间差异的可能解释涉及方法学、所用激素方案和研究人群的差异。<ref name="Grodstein-2003">{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}</ref><ref name="Vandenbroucke-2009">{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 ~~| s2cid = 44991220~~ }}</ref>在随机对照试验发表后，激素替代疗法的使用减少了。<ref name="Hsu-2009">{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}</ref>

+

* 在2002年之前，<ref name="Rubin-2006"/>基于观察性研究，医生为绝经后妇女开激素替代疗法以预防心肌梗死是常规。然而，在2002年和2004年，妇女健康倡议发表的随机对照试验声称，服用雌激素加孕激素的激素替代疗法的妇女比服用安慰剂的妇女心肌梗死的发生率更高，并且仅服用雌激素的激素替代疗法不会降低冠心病的发病率。<ref name="Rossouw-2002"/><ref name="Anderson-2004">{{Cite journal |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}</ref>观察性研究和随机对照试验之间差异的可能解释涉及方法学、所用激素方案和研究人群的差异。<ref name="Grodstein-2003">{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}</ref><ref name="Vandenbroucke-2009">{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 }}</ref>在随机对照试验发表后，激素替代疗法的使用减少了。<ref name="Hsu-2009">{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}</ref>

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=== 时间和花销 ===

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RCT可能很贵；<ref name="Sanson-Fisher-2007"/>一项研究发现，在2000年之前，由国家神经障碍和中风研究所资助的28个三期随机对照试验总费用为3.35亿美元，<ref name="Johnston-2006">{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = The Lancet | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 ~~| s2cid = 41035177~~ }}</ref>平均每个RCT花费1200万美元。尽管如此，随机对照试验的投资回报可能很高，因为同一项研究预测，根据对质量调整生命年的评估，28个随机对照试验产生的“10年社会净收益”是试验项目成本的46倍，等于当时的人均国内生产总值平均值。<ref name="Johnston-2006"/>

+

RCT可能很贵；<ref name="Sanson-Fisher-2007"/>一项研究发现，在2000年之前，由国家神经障碍和中风研究所资助的28个三期随机对照试验总费用为3.35亿美元，<ref name="Johnston-2006">{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = The Lancet | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 }}</ref>平均每个RCT花费1200万美元。尽管如此，随机对照试验的投资回报可能很高，因为同一项研究预测，根据对质量调整生命年的评估，28个随机对照试验产生的“10年社会净收益”是试验项目成本的46倍，等于当时的人均国内生产总值平均值。<ref name="Johnston-2006"/>

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=== 犯罪学 ===

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2005年的一项审查发现，1982-2004年发表了83项犯罪学随机实验，而1957-1981年只发表了35项。<ref name="Farrington-2005">{{cite journal |vauthors=Farrington DP, Welsh BC |year= 2005 |title= Randomized experiments in criminology: What have we learned in the last two decades? |journal=Journal of Experimental Criminology|volume=1 |issue=1 |pages= 9–38 |doi= 10.1007/s11292-004-6460-0 ~~|s2cid= 145758503~~ }}</ref>作者将他们发现的研究分为五类:“警务”、“预防”、“惩戒”、“法院”和“社区”。<ref name="Farrington-2005"/> Hollin (2008)只关注犯罪行为项目，他认为随机对照试验可能很难实施（例如，如果RCT要求“判刑时随机将罪犯分配到项目中”），因此准实验设计的实验仍然是必要的。<ref>{{cite journal |author=Hollin CR |year= 2008 |title= Evaluating offending behaviour programmes: does only randomization glister? |journal=Criminology and Criminal Justice |volume=8 |issue=1 |pages= 89–106 |doi= 10.1177/1748895807085871 ~~|s2cid= 141222135~~ }}</ref>

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2005年的一项审查发现，1982-2004年发表了83项犯罪学随机实验，而1957-1981年只发表了35项。<ref name="Farrington-2005">{{cite journal |vauthors=Farrington DP, Welsh BC |year= 2005 |title= Randomized experiments in criminology: What have we learned in the last two decades? |journal=Journal of Experimental Criminology|volume=1 |issue=1 |pages= 9–38 |doi= 10.1007/s11292-004-6460-0 }}</ref>作者将他们发现的研究分为五类:“警务”、“预防”、“惩戒”、“法院”和“社区”。<ref name="Farrington-2005"/> Hollin (2008)只关注犯罪行为项目，他认为随机对照试验可能很难实施（例如，如果RCT要求“判刑时随机将罪犯分配到项目中”），因此准实验设计的实验仍然是必要的。<ref>{{cite journal |author=Hollin CR |year= 2008 |title= Evaluating offending behaviour programmes: does only randomization glister? |journal=Criminology and Criminal Justice |volume=8 |issue=1 |pages= 89–106 |doi= 10.1177/1748895807085871}}</ref>

=== 教育 ===

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RCT已被用于评估一些教育干预措施。从1980年到2016年，已经发表了1000多份随机对照试验报告。<ref>{{Cite journal|last1=Connolly|first1=Paul|last2=Keenan|first2=Ciara|last3=Urbanska|first3=Karolina|date=2018-07-09|title=The trials of evidence-based practice in education: a systematic review of randomised controlled trials in education research 1980–2016|journal=Educational Research|volume=60|issue=3|language=en|pages=276–291|doi=10.1080/00131881.2018.1493353|issn=0013-1881|url=https://pure.qub.ac.uk/portal/en/publications/the-trials-of-evidencebased-practice-in-education-a-systematic-review-of-randomised-controlled-trials-in-education-research-19802016(34e5d239-e91a-4807-96eb-a926022cbb14).html|doi-access=free}}</ref>例如，2009年的一项研究随机选择了260名小学教师的教室，让他们接受或不接受行为筛查、课堂干预和家长培训，然后测量他们学生的行为和学业表现。<ref>{{cite journal |vauthors=Walker HM, Seeley JR, Small J, Severson HH, Graham BA, Feil EG, Serna L, Golly AM, Forness SR |year= 2009 |title=A randomized controlled trial of the First Step to Success early intervention. Demonstration of program efficacy outcomes in a diverse, urban school district |journal=Journal of Emotional and Behavioral Disorders |volume= 17 |issue=4 |pages=197–212 |doi= 10.1177/1063426609341645 ~~|s2cid= 144571336~~ }}</ref>另一项2009年的研究对678名一年级儿童进行了随机课堂，让他们接受以课堂为中心的干预、以家长为中心的干预或不干预，然后跟踪他们19岁的学习成绩。<ref>{{cite journal |vauthors=Bradshaw CP, Zmuda JH, Kellam SG, Ialongo NS |year=2009 |title= Longitudinal impact of two universal preventive interventions in first grade on educational outcomes in high school |journal= Journal of Educational Psychology|volume=101 |issue=4 |pages=926–937 |doi= 10.1037/a0016586 |pmid=23766545 |pmc=3678772 }}</ref>

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RCT已被用于评估一些教育干预措施。从1980年到2016年，已经发表了1000多份随机对照试验报告。<ref>{{Cite journal|last1=Connolly|first1=Paul|last2=Keenan|first2=Ciara|last3=Urbanska|first3=Karolina|date=2018-07-09|title=The trials of evidence-based practice in education: a systematic review of randomised controlled trials in education research 1980–2016|journal=Educational Research|volume=60|issue=3|language=en|pages=276–291|doi=10.1080/00131881.2018.1493353|issn=0013-1881|url=https://pure.qub.ac.uk/portal/en/publications/the-trials-of-evidencebased-practice-in-education-a-systematic-review-of-randomised-controlled-trials-in-education-research-19802016(34e5d239-e91a-4807-96eb-a926022cbb14).html|doi-access=free}}</ref>例如，2009年的一项研究随机选择了260名小学教师的教室，让他们接受或不接受行为筛查、课堂干预和家长培训，然后测量他们学生的行为和学业表现。<ref>{{cite journal |vauthors=Walker HM, Seeley JR, Small J, Severson HH, Graham BA, Feil EG, Serna L, Golly AM, Forness SR |year= 2009 |title=A randomized controlled trial of the First Step to Success early intervention. Demonstration of program efficacy outcomes in a diverse, urban school district |journal=Journal of Emotional and Behavioral Disorders |volume= 17 |issue=4 |pages=197–212 |doi= 10.1177/1063426609341645 }}</ref>另一项2009年的研究对678名一年级儿童进行了随机课堂，让他们接受以课堂为中心的干预、以家长为中心的干预或不干预，然后跟踪他们19岁的学习成绩。<ref>{{cite journal |vauthors=Bradshaw CP, Zmuda JH, Kellam SG, Ialongo NS |year=2009 |title= Longitudinal impact of two universal preventive interventions in first grade on educational outcomes in high school |journal= Journal of Educational Psychology|volume=101 |issue=4 |pages=926–937 |doi= 10.1037/a0016586 |pmid=23766545 |pmc=3678772 }}</ref>

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