title: Design and analysis of prostate cancer trials.
abstract: This paper presents an overview of various statistical concepts related to the design and analysis of prostate cancer trials: the need for randomization, stratification for prognostic factors, sample size determination, trial objectives, the choice of a control group, patient entry criteria, the number of treatments to be compared, the choice of endpoints, analysis by the intent to treat principle, interim statistical analysis and early stopping rule, and subgroup analyses.
authors.affiliation: Eortc Data Center, Brussels, Belgium.
authors.forename: R
authors.initials: R
authors.lastname: Sylvester
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D012494:Sampling Studies; D013223:Statistics as Topic