Randomised trials in ovarian cancer: trial design considerations

被引:6
|
作者
Brady, MF
Thigpen, JT
Vermorken, JB
Parmar, MKB
机构
[1] Roswell Pk Canc Inst, GOG Stat Off, Buffalo, NY 14263 USA
[2] Univ Mississippi, Sch Med, Dept Med, Jackson, MS 39216 USA
[3] Univ Antwerp Hosp, Dept Med Oncol, Edegem, Belgium
[4] MRC, Canc Trials Off, Cambridge, England
关键词
end point selection; progression-free survival; response; survival; trial size;
D O I
10.1023/A:1008319704310
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:75 / 82
页数:8
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