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. Scientifically, the randomized controlled trial is the most powerful way to determine a result ascribable only to the trial treatment. Although randomized controlled trials can be imperfect or improperly conducted, they are designed to circumvent biased behavior by investigators. 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.