Editing Randomized controlled trial (section)

== History ==
The first reported [[clinical trial]] was conducted by [[James Lind]] in 1747 to identify a treatment for [[scurvy]].<ref>{{Cite journal |vauthors=Dunn PM |date=January 1997 |title=James Lind (1716-94) of Edinburgh and the treatment of scurvy |journal=Archives of Disease in Childhood. Fetal and Neonatal Edition |volume=76 |issue=1 |pages=F64–F65 |doi=10.1136/fn.76.1.f64 |pmc=1720613 |pmid=9059193}}</ref> The first blind experiment was conducted by the [[Royal Commission on Animal Magnetism|French Royal Commission on Animal Magnetism]] in 1784 to investigate the claims of [[animal magnetism|mesmerism]]. An early essay advocating the blinding of researchers came from [[Claude Bernard]] in the latter half of the 19th century.{{vague|date=April 2019}} Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent [[Age of Enlightenment|Enlightenment]]-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.<ref>{{Cite journal |vauthors=Daston L |year=2005 |title=Scientific Error and the Ethos of Belief |journal=Social Research |volume=72 |page=18 |doi=10.1353/sor.2005.0016 |s2cid=141036212 |number=1}}</ref> The first study recorded to have a blinded researcher was published in 1907 by [[W. H. R. Rivers]] and H. N. Webber to investigate the effects of caffeine.<ref name="pmid16992882">{{Cite journal |vauthors=Rivers WH, Webber HN |date=August 1907 |title=The action of caffeine on the capacity for muscular work |journal=The Journal of Physiology |volume=36 |issue=1 |pages=33–47 |doi=10.1113/jphysiol.1907.sp001215 |pmc=1533733 |pmid=16992882}}</ref>

[[Randomized experiment]]s first appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,<ref>{{Cite journal |vauthors=[[Charles Sanders Peirce|Peirce CS]], [[Joseph Jastrow|Jastrow J]] |year=1885 |title=On Small Differences in Sensation |url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm |journal=Memoirs of the National Academy of Sciences |volume=3 |pages=73–83}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm</ref> and in [[school of education|education]].<ref>{{Cite journal |author-link=Ian Hacking |vauthors=Hacking I |date=September 1988 |title=Telepathy: Origins of Randomization in Experimental Design |journal=[[Isis (journal)|Isis]] |series=A Special Issue on Artifact and Experiment |volume=79 |issue=3 |pages=427–451 |doi=10.1086/354775 |jstor=234674 |mr=1013489 |s2cid=52201011}}</ref><ref>{{Cite journal |author-link=Stephen M. Stigler |vauthors=Stigler SM |date=November 1992 |title=A Historical View of Statistical Concepts in Psychology and Educational Research |journal=American Journal of Education |volume=101 |issue=1 |pages=60–70 |doi=10.1086/444032 |s2cid=143685203}}</ref><ref>{{Cite journal |vauthors=Dehue T |date=December 1997 |title=Deception, efficiency, and random groups. Psychology and the gradual origination of the random group design |url=https://pure.rug.nl/ws/files/71855616/237831.pdf |journal=Isis; an International Review Devoted to the History of Science and Its Cultural Influences |volume=88 |issue=4 |pages=653–673 |doi=10.1086/383850 |pmid=9519574 |s2cid=23526321}}</ref> The earliest experiments comparing [[treatment and control groups]] were published by [[Robert S. Woodworth|Robert Woodworth]] and [[Edward Thorndike]] in 1901,<ref>{{Cite journal |vauthors=Woodworth RS, ThorndikeEL |year=1901 |title=The influence of improvement in one mental function upon the efficiency of other functions (I) |url=https://gwern.net/doc/psychology/1901-thorndike.pdf |journal=Psychological Review |volume=8 |issue=3 |page=247|doi=10.1037/h0074898 }}</ref> and by [[John Edgar Coover|John E. Coover]] and [[Frank Angell]] in 1907.<ref>{{Cite journal |vauthors=Coover JE, Angell F |date=1907 |title=General Practice Effect of Special Exercise |url=https://www.jstor.org/stable/1412596 |journal=The American Journal of Psychology |volume=18 |issue=3 |pages=328–340 |doi=10.2307/1412596 |jstor=1412596 |issn=0002-9556|url-access=subscription }}</ref><ref>{{Cite journal |vauthors=Dehue T |date=2000 |title=From deception trials to control reagents: The introduction of the control group about a century ago. |url=https://doi.apa.org/doi/10.1037/0003-066X.55.2.264 |journal=American Psychologist |language=en |volume=55 |issue=2 |pages=264–268 |doi=10.1037/0003-066X.55.2.264 |issn=1935-990X |archive-url=https://web.archive.org/web/20240712172031/https://www.rug.nl/staff/trudy.dehue/11%20deception%20trials.pdf |archive-date=12 Jul 2024|url-access=subscription }}</ref>

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" >
According to Denis Conniffe:
{{blockquote|
Ronald A. Fisher was "interested in application and in the popularization
of statistical methods and his early book ''[[Statistical Methods for Research Workers]]'', published in 1925, went through many editions and
motivated and influenced the practical use of statistics in many fields of
study. His ''Design of Experiments'' (1935) <!-- was also crucially fundamental
in the promotion of--> [promoted] statistical technique and application. In that book he
emphasized examples and how to design experiments systematically from
a statistical point of view. The mathematical justification of the methods
described was not stressed and, indeed, proofs were often barely sketched
or omitted altogether ..., a fact which led [[Henry Mann|H. B. Mann]] to fill the gaps with a rigorous mathematical treatment in his well known treatise, {{harvtxt|Mann|1949}}."
}}
{{Cite news |year=1990–1991 |title=R. A. Fisher and the development of statistics—a view in his centenary year |url=http://www.tara.tcd.ie/jspui/handle/2262/2764 |work=Journal of the Statistical and Social Inquiry Society of Ireland |publisher=[[Statistical and Social Inquiry Society of Ireland]] |location=Dublin |page=87 |volume=XXVI |issue=3 |issn=0081-4776 |vauthors=Conniffe D |hdl=2262/2764}}
{{pb}}{{Cite book |author-link=Henry Mann |title=Analysis and design of experiments: Analysis of variance and analysis of variance designs |vauthors=Mann HB |publisher=Dover Publications |year=1949 |location=New York |mr=32177}}</ref>

The first published Randomized Controlled Trial 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 |vauthors=((Streptomycin in Tuberculosis Trials Committee)) |date=October 1948 |title=STREPTOMYCIN treatment of pulmonary tuberculosis |journal=British Medical Journal |volume=2 |issue=4582 |pages=769–782 |doi=10.1136/bmj.2.4582.769 |pmc=2091872 |pmid=18890300}}</ref><ref name="Brown-1998">{{Cite news |date=1998-11-02 |title=Landmark study made research resistant to bias |newspaper=[[Washington Post]] |vauthors=Brown D}}</ref><ref name="Shikata-2006">{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H |date=November 2006 |title=Comparison of effects in randomized controlled trials with observational studies in digestive surgery |journal=Annals of Surgery |volume=244 |issue=5 |pages=668–676 |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 |date=December 2004 |title=Randomized controlled trials |journal=AJR. American Journal of Roentgenology |volume=183 |issue=6 |pages=1539–1544 |doi=10.2214/ajr.183.6.01831539 |pmid=15547188 |s2cid=5376391}}</ref>

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 |date=2 November 2020 |title=Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |access-date=3 November 2020 |website=The Guardian |vauthors=Ferry G}}</ref>

By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine.<ref name="Meldrum-2000">{{Cite journal |vauthors=Meldrum ML |date=August 2000 |title=A brief history of the randomized controlled trial. From oranges and lemons to the gold standard |url=https://zenodo.org/record/1260107 |journal=Hematology/Oncology Clinics of North America |volume=14 |issue=4 |pages=745–60, vii |doi=10.1016/S0889-8588(05)70309-9 |pmid=10949771}}</ref>  As of 2004, more than 150,000 RCTs were in the [[Cochrane Library]].<ref name="Stolberg-2004" />  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.<ref name="Schulz-2010" /><ref name="Moher-2010" /> 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.{{cn|date=March 2025}}