title: Challenge of surrogate endpoints.
abstract: Surrogate endpoints are biomarkers that are intended to substitute for clinical endpoints. They have been used to find novel therapeutic targets, improve the statistical power and shorten the duration of clinical trials, and control the cost of conducting research studies. The more generalized use of surrogate endpoints in clinical decision making can be hazardous and should be undertaken with great caution. This article reviews prior work with surrogate endpoints and highlights caveats and lessons learned from studies using surrogate endpoints.
authors.affiliation: Department of Medicine, MCHE-MED Cardiology Service, Brooke Army Medical Center, Ft. Sam Houston, Texas 78234, USA. james.furgerson@amedd.army.mil
authors.forename: James L
authors.initials: JL
authors.lastname: Furgerson
authors.forename: William N
authors.initials: WN
authors.lastname: Hannah
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Thompson
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D003625:Data Collection; D018450:Disease Progression; D006801:Humans; D012107:Research Design
chemical_list: D015415:Biomarkers