PLACEBOS AND PRINCIPLES - A TRIAL OF ONDANSETRON

Special ethical concerns exist about the use of placebo controls. A placebo-controlled study must answer four questions: (1) Was any therapeutic intervention available that could be reasonably assumed to be less harmful than the placebo control? (2) Did the placebo control pose more than minimal risk to those patients? (3) Was the study designed in every way possible to minimize potential harm to the patients receiving placebo? (4) Were the patients fully and accurately informed of the additional risk of being in the placebo group? By answering these questions, the author evaluates a study comparing oral ondansetron to placebo for cancer patients receiving emetogenic chemotherapy.