title: Biomarkers and surrogate endpoints in renal transplantation: present status and considerations for clinical trial design.
abstract: Of major importance in clinical trials is the ability to predict individual patient outcome or endpoints using biomarkers, also known as variables or predictors, in as safe, efficient, and accurate a manner as possible. This review addresses the concepts and possible strategies for use of predictor and surrogate biomarkers in the design of clinical trials in renal transplantation. The statistical concepts apply equally well to other organ grafts.
authors.affiliation: Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Rockville, MD, USA.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Lachenbruch
authors.forename: Amy S
authors.initials: AS
authors.lastname: Rosenberg
authors.forename: Ezio
authors.initials: E
authors.lastname: Bonvini
authors.forename: Marc W
authors.initials: MW
authors.lastname: Cavaillé-Coll
authors.forename: Robert B
authors.initials: RB
authors.lastname: Colvin
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D006084:Graft Rejection; D006801:Humans; D016030:Kidney Transplantation / Q000379:methods*; D012044:Regression Analysis; D012107:Research Design; D012307:Risk Factors
chemical_list: D015415:Biomarkers