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randomized controlled trial : ウィキペディア英語版
randomized controlled trial

A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment, where the people being studied are randomly allocated one or other of the different treatments under study. The RCT is often considered the gold standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of medical intervention and may provide information about adverse effects, such as drug reactions. Random assignment of intervention is done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins.
Random allocation in real trials is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, and follow-up calls, should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.
The terms "RCT" and randomized trial are sometimes used synonymously, but the methodologically sound practice is to reserve the "RCT" name only for trials that contain control groups, in which groups receiving the experimental treatment are compared with control groups receiving no treatment (a placebo-controlled study) or a previously tested treatment (a positive-control study). The term "randomized trials" omits mention of controls and can describe studies that compare multiple treatment groups with each other (in the absence of a control group). Similarly, although the "RCT" name is sometimes expanded as "randomized clinical trial" or "randomized comparative trial", the methodologically sound practice, to avoid ambiguity in the scientific literature, is to retain "control" in the definition of "RCT" and thus reserve that name only for trials that contain controls. Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trials is a methodologically sound alternate expansion for "RCT" in RCTs that concern clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.
==History==
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.〔https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1720613/pdf/v076p00F64.pdf〕 Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce,〔 http://psychclassics.yorku.ca/Peirce/small-diffs.htm〕 and in education. Later, randomized experiments appeared in agriculture, due to Jerzy Neyman〔Neyman, Jerzy. 1923 (). "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.
〕 and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.〔
According to ,

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) () 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 H. B. Mann to fill the gaps with a rigorous mathematical treatment in his well known treatise, ."

Page 87:


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.
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.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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