Clinical trials

✍ Scribed by Mogens Blichert-Toft; Henning Mouridsen; Knud West Andersen

• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 735 KB
• Volume: 12
• Category: Article
• ISSN: 8756-0437
• DOI: 10.1002/(sici)1098-2388(199601/02)12:1<32::aid-ssu5>3.0.co;2-7

✦ Synopsis

Randomized clinical trials are regarded as the most credible way of generating scientific data to compare therapies for the treatment of human disease. However, randomized studies present dificulties in their execution in countries nhere it is necessary to obtain informed patient consent. . . .

M. Zelen, 1990

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.