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第9行： + − The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]]. − The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.+ − 试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。 + − The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.<ref name="Moher-2010">{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}</ref> Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].+ − The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases. − 在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。+ − − − − A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.<ref name="hannan">{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}</ref> − − A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health. − − 一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。 − − − − − − The terms "RCT" and "'''randomized trial'''" are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.<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> Similarly, the [[initialism]] is sometimes expanded as "'''randomized clinical trial'''" or "'''randomized comparative trial'''", leading to ambiguity in the [[scientific literature]].<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> Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];<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|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}</ref> however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]]. − − The terms "RCT" and "randomized trial" are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as "randomized clinical trial" or "randomized comparative trial", leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences. − − “ 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。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。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; 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。 − − − − {{toc limit}} − − − − == History == 第55行：
第28行： − [[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,<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> and in [[school of education|education]].<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)|Isis]]|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)|Isis]]|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>+ − Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education. − 在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。+ − In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]<ref>Neyman, Jerzy. 1923 [1990]. "On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9." ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.</ref> and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.<ref name="Conniffe" />+ − In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments. − 在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。+ − <p>The first published RCT in medicine appeared in the 1948 paper entitled "[[Streptomycin]] treatment of pulmonary [[tuberculosis]]", which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.<ref name="MRC-1948">{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}</ref><ref name="Brown-1998">{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}</ref><ref name="Shikata-2006">{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}</ref> One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.<ref name="Stolberg-2004">{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}</ref> − <p>The first published RCT in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis", which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT. − − <p>医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 − − <p> − − <p>Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.<ref>{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}</ref> − − <p>Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s. − − <p>20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。 − − <p> − + − <p>到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。 − +
无编辑摘要
试验可能采用了盲法 blinded experiment，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。<ref name="Moher-2010">{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}</ref>盲法减少了其他形式的实验者和主体偏见。
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。<ref name="hannan">{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}</ref>
“ 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|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。
== 历史 ==
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]
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)|Isis]]|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)|Isis]]|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。
在20世纪早期，Jerzy Neyman<ref>Neyman, Jerzy. 1923 [1990]. "On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9." ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.</ref>和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。<ref name="Conniffe" />
医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。<ref name="MRC-1948">{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}</ref><ref name="Brown-1998">{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}</ref><ref name="Shikata-2006">{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}</ref>这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。<ref name="Stolberg-2004">{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}</ref>
<p>20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。<ref>{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}</ref>
<p>By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.
<p>By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.
<p>By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.
<p>到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。
== Ethics ==
== ==
Although the principle of clinical equipoise ("genuine uncertainty within the expert medical community... about the preferred treatment") common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, "collective equipoise" can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical "for most therapeutic trials."[28][29]
Although the principle of clinical equipoise ("genuine uncertainty within the expert medical community... about the preferred treatment") common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, "collective equipoise" can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical "for most therapeutic trials."[28][29]