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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. [3] [4]
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.
(where ! denotes factorial) possible run sequences (or ways to order the experimental trials). Because of the replication, the number of unique orderings is 90 (since 90 = 6!/(2!*2!*2!)). An example of an unrandomized design would be to always run 2 replications for the first level, then 2 for the second level, and finally 2 for the third level.
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]
Randomized, controlled, crossover experiments are especially important in health care. In a randomized clinical trial, the subjects are randomly assigned treatments. When such a trial is a repeated measures design, the subjects are randomly assigned to a sequence of treatments.
In probability theory, an experiment or trial (see below) is any procedure that can be infinitely repeated and has a well-defined set of possible outcomes, known as the sample space. [1] An experiment is said to be random if it has more than one possible outcome, and deterministic if it has only one.
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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]