title: Statistical controversies in clinical research: an initial evaluation of a surrogate end point using a single randomized clinical trial and the Prentice criteria.
abstract: Surrogate end point research has grown in recent years with the increasing development and usage of biomarkers in clinical research. Surrogacy analysis is derived through randomized clinical trial data and it is carried out at the individual level and at the trial level. A common surrogate analysis at the individual level is the application of the Prentice criteria. An approach for the evaluation of the Prentice criteria is discussed, with a focus on its most difficult component, the determination of whether the treatment effect is captured by the surrogate. An interpretation of this criterion is illustrated using data from a randomized clinical trial in prostate cancer.
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, USA hellerg@mskcc.org.
authors.forename: G
authors.initials: G
authors.lastname: Heller
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D019317:Evidence-Based Medicine; D006801:Humans; D015233:Models, Statistical; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015203:Reproducibility of Results
chemical_list: D015415:Biomarkers
keywords: Prentice criteria; equivalence test; randomized clinical trial; surrogate end point