Bias in Treatment Assignment in Controlled Clinical Trials
Chalmers, Thomas C.
Sacks, Henry S.
New England Journal of Medicine. 1983 Dec 1; 309(22): 1358-1361.
The suggestion that bias in the assignment of patients to treatment or control groups may be an important determinant of the outcome of clinical trials was studied through a statistical analysis of 145 papers on controlled trials of the management of acute myocardial infarction. The papers were divided into three groups according to whether controls were selected by a blinded randomization process, an unblinded randomization process, or a nonrandom process. Maldistribution of prognostic variables in pretreatment assignment was demonstrated for controlled trials in which the investigator was able to anticipate treatment assignment before patient selection. (KIE abstract)
Clinical Trials; Control Groups; Controlled Clinical Trials; Consent; Disclosure; Drugs; Heart Diseases; Human Experimentation; Informed Consent; Mortality; Patients; Prognosis; Random Selection; Research; Research Design; Selection for Treatment; Selection of Subjects; Statistics; Therapeutic Research;
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