Clinical trials.

Abstract

The randomized clinical trial is a scientific method for solving clinical problems. The method is typically employed before a new type of treatment is offered on a major scale in order to safeguard patients against a less curative therapy. Especially with regard to cancer treatment, randomized studies are conducted in increasing numbers. However, there remains a considerable discrepancy between the actual number of patients entered in randomized trials and the eligible number available. The demand of obtaining informed consent is a major reason for not entering patients into randomized studies. The critical item is whether information about randomization as a method for allocation should be disclosed to the patient. The doctor feels embarrassed not to be able to advise and support the patient in decision making about treatment and finds his or her role as the caring doctor replaced by the roulette. The requirement to seek informed consent has increased the rate of denial to participate in randomized trials from a few percent, up to about 50% or even higher.