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The Ethics of the Randomized Clinical Trial
New England Journal of Medicine, 1982THE ethics of medical experimentation on human subjects has attracted much attention in recent years. There has, however, been rather less attention paid to the special ethical problems and dilemmas posed by the randomized clinical trial. The sheer number of such trials, the risks and costs that they involve, and the dangers that are posed both by ...
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Randomization: The forgotten component of the randomized clinical trial
Statistics in Medicine, 2018“…The customary test for an observed difference…is based on an enumeration of the probabilities, on the initial hypothesis that two treatments do not differ in their effects,…of all the various results which would occur if the trial were repeated indefinitely with different random samples of the same size as those actually used.” –Peter Armitage ...
William F. Rosenberger +2 more
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Components of a randomized clinical trial
Journal of Periodontal Research, 1997The purpose of this paper is to discuss a number of components associated with the design, development and conduct of a randomized clinical trial (RCT). In a RCT, a patient is entered into a protocol in which therapy is randomly assigned. Thus, neither the patient nor the care provider have active roles in deciding treatment.
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Randomization tests for multiarmed randomized clinical trials
Statistics in Medicine, 2019We examine the use of randomization‐based inference for analyzing multiarmed randomized clinical trials, including the application of conditional randomization tests to multiple comparisons. The view is taken that the linkage of the statistical test to the experimental design (randomization procedure) should be recognized.
Yanying Wang +2 more
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Why Randomize Clinical Trials?
Pediatric Hematology and Oncology, 1998It is easy to conduct an experiment in such a way that no useful inferences can be made.—Cochran and Cox [1]
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The role of randomization in clinical trials
Statistics in Medicine, 1982AbstractRandom assignment of treatments is an essential feature of experimental design in general and clinical trials in particular. It provides broad comparability of treatment groups and validates the use of statistical methods for the analysis of results.
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Nursing Research, 1989
The clinical trial is a randomized prospective study of human subjects in which the effectiveness of an intervention is compared against a control. Such a trial is considered to be a critical test of an innovative therapy. Trials require careful design and planning to be scientifically valid and clinically pertinent.
MARILYN S. FETTER +6 more
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The clinical trial is a randomized prospective study of human subjects in which the effectiveness of an intervention is compared against a control. Such a trial is considered to be a critical test of an innovative therapy. Trials require careful design and planning to be scientifically valid and clinically pertinent.
MARILYN S. FETTER +6 more
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The cornerstones of randomized clinical trials
International Urology and NephrologyRandomized clinical trials (RCTs) are pivotal in medical research, offering critical evidence on the efficacy and safety of treatments. This paper explores the distinct purposes and designs of superiority, non-inferiority, equivalence, and pragmatic trials, each addressing unique research questions. Superiority trials aim to demonstrate a new treatment'
Gori, Mercedes +8 more
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The BaSICS randomized clinical trial
Internal and Emergency Medicine, 2022Barbara Rocchi +3 more
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Randomized clinical trials in neurosurgery
Neurosurgery, 1982Fifty-one randomized trials of neurosurgical topics have been identified. These have been analyzed for content, quality of reporting, and quality of statistical design and analysis. In general, there were major omissions in the reporting of critical portions of the studies, the statistical analysis was highly variable in quality, and the statistical ...
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