title: Implications of geographical variation on clinical outcomes of cardiovascular trials.
abstract: Cardiovascular clinical trials are increasingly conducted globally as a means to reduce costs, expedite timelines, provide broad applicability, and satisfy regulatory authorities. Potential problems with trial globalization include regional differences in patient characteristics, medical practice patterns, and health policies which may influence outcomes and limit generalizability. Moreover, concerns have been raised about ethical misconduct and unsatisfactory quality oversight in regions with less trial experience and infrastructure. This article reviews geographical differences in cardiovascular trials in heart failure, acute coronary syndromes, hypertension and atrial fibrillation. It also explores potential explanations for these differences and methods to standardize the presentation of trial results. This review is based on discussions between basic scientists and clinical trialists at the 8th Global Cardio Vascular Clinical Trialists Forum 2011 in Paris, France, from December 2 to 3.
authors.affiliation: Duke University Medical Center, Durham, NC, USA. robert.mentz@duke.edu
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Kaski
authors.forename: Gheorghe-Andrei
authors.initials: GA
authors.lastname: Dan
authors.forename: Sidney
authors.initials: S
authors.lastname: Goldstein
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.forename: Angeles
authors.initials: A
authors.lastname: Alonso-Garcia
authors.forename: Luis M
authors.initials: LM
authors.lastname: Ruilope
authors.forename: Felipe A
authors.initials: FA
authors.lastname: Martinez
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.forename: Christopher M
authors.initials: CM
authors.lastname: O'Connor
mesh_terms: D002318:Cardiovascular Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D005843:Geography; D006801:Humans; D038622:Internationality; D016896:Treatment Outcome