The Gynecologic Cancer Intergroup (GCIG): history and current status

Abstract

Randomized trials are considered the definitive source of evidence for guiding decisions in clinical practice, especially when the magnitude of the expected treatment difference is at best moderate. Goals of these trials are (i) to determine the effectiveness of a treatment relative to the best current standard of care, or (ii) to assess whether a new treatment is as effective as the standard, but associated with less toxicity, cost or better quality of life. The design, execution and analysis of such trials must be based on sound scientific and ethical criteria, but it is also crucial that they have sufficient statistical power to detect a realistic and clinically important difference in overall or progression-free survival [1]. Lack of statistical power owing to small numbers of enrolled patients has been a serious problem in ovarian cancer trials in the past. Both progression-free and overall survival can be considered as important end points (although progressionfree survival is also often considered as a surrogate end point for survival) and are of obvious clinical relevance for the patients, just as are quality of life or symptoms scores