title: Conduct of clinical trials in acute heart failure: regional differences in heart failure clinical trials.
abstract: Clinical trials are often conducted globally. Differences in standard of care, patient populations including genetic and phenotypic differences, disease etiologies, rates of comorbidities, ascertainment of endpoints, and differences in concomitant therapies and medical culture may influence subsequent outcomes. There has been little consensus on how clinical trial results should be evaluated. This article reviews the differences in cardiovascular trial results by geographic region, offers potential explanations for these differences, and suggests methods for standardization of trial results.
authors.affiliation: Duke University Medical Center, 2400 Pratt Street, Durham, NC 27710, USA. mona.fiuzat@duke.edu
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D000208:Acute Disease; D002986:Clinical Trials as Topic / Q000379:methods*; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D018579:Patient Selection; D014481:United States