Randomised trials in ovarian cancer: trial design considerations

Randomised clinical trials are considered the definitive source of evidence for guiding decisions in clinical practice. The concept of a clinical tria l is based on sound scientific, ethical, and practical principles. The stre ngth of evidence that an individual trial provides is assessed on the manne r in which these principles are incorporated into the design and execution of the trial. Since the way these principles are incorporated into a trial is judgmental, the strength of evidence from an individual trial is a matte r of degree. The purpose of this paper is to present some of the scientific , ethical and practical considerations surrounding the selection of endpoin ts and determination of sample size for trials in ovarian cancer.