Randomized controlled trials are the gold standard of scientific testing for new medical interventions. They have become the standard that must be met by pharmaceutical companies in the process of working out what level of efficacy and safety can be achieved by an experimental drug.
The three words for this method of clinical testing - randomized controlled trial (RCT) - represent important elements of the scientific design:
- Randomized - the decision about whether a patient in the trial receives the new treatment or the control treatment (or placebo ) is made randomly Controlled - the trial uses a control group for comparison or reference. In the control group, the patients do not receive the new treatment being tested, but receive a reference treatment or placebo instead Trial - the drug or treatment is on trial during an RCT; it will be approved for wider use only if the results of the testing program indicate that there is a worthwhile level of efficacy, which must be balanced against an acceptable level of adverse effects (safety).
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