The American journal of medicine
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Randomized Controlled Trial Clinical Trial
The randomized controlled clinical trial. Scientific and ethical bases.
Randomized controlled trials are increasingly accepted in principle but not always in practice, particularly for surgical therapies. Successful surgical randomized controlled trials demonstrate their feasibility, and reports of uncontrolled surgical trials now commonly bear a statement that a definitive answer requires a controlled trial. ⋯ With candor in informed consent, the equal chance not to get a trial treatment makes the randomized controlled trial the most ethical design. Thus, scientific, behavioral, and ethical cases support the randomized controlled trial as the optimal method for investigation of nearly all therapeutic innovations and as a requirement for publication.