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A randomized controlled trial (or randomized control trial; [2] RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices , diagnostic procedures , diets or other medical treatments.
In the statistical theory of design of experiments, randomization involves randomly allocating the experimental units across the treatment groups.For example, if an experiment compares a new drug against a standard drug, then the patients should be allocated to either the new drug or to the standard drug control using randomization.
In medicine an intention-to-treat (ITT) analysis of the results of a randomized controlled trial is based on the initial treatment assignment and not on the treatment eventually received. ITT analysis is intended to avoid various misleading artifacts that can arise in intervention research such as non-random attrition of participants from the ...
In a randomized trial (i.e., an experimental study), the average treatment effect can be estimated from a sample using a comparison in mean outcomes for treated and untreated units. However, the ATE is generally understood as a causal parameter (i.e., an estimate or property of a population ) that a researcher desires to know, defined without ...
Randomization is a statistical process in which a random mechanism is employed to select a sample from a population or assign subjects to different groups. [1] [2] [3] The process is crucial in ensuring the random allocation of experimental units or treatment protocols, thereby minimizing selection bias and enhancing the statistical validity. [4]
Advantages of cluster-randomised controlled trials over individually randomised controlled trials include: The ability to study interventions that cannot be directed toward selected individuals (e.g., a radio show about lifestyle changes) and the ability to control for "contamination" across individuals (e.g., one individual's changing behaviors may influence another individual to do so).
A trial in which random allocation is used to determine the order in which an experimental and a control intervention are given to a single patient is an N of 1 randomized controlled trial. Some N of 1 trials involve randomized assignment and blinding, but the order of experimental and control interventions can also be fixed by the researcher. [2]
Clinical trials are medical research studies conducted on human subjects. [1] The human subjects are assigned to one or more interventions, and the investigators evaluate the effects of those interventions. [1] [2] The progress and results of clinical trials are analyzed statistically. [3] [4]