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 trial is based on sound scientific, ethical, and practical principles. The strength of evidence that an individual trial provides is assessed on the manner 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 matter of degree. The purpose of this paper is to present some of the scientific, ethical and practical considerations surrounding the selection of endpoints and determination of sample size for trials in ovarian cancer.
Brady
M F
MF
GOG Statistical Office, Roswell Park Cancer Institute, Buffalo, USA. brady@gogstats.med.buffalo.edu
Thigpen
J T
JT
Vermorken
J B
JB
Parmar
M K
MK
D005260:Female; D006801:Humans; D008432:Mathematical Computing; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome