Implications of geographical variation on clinical outcomes of cardiovascular trials.


Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Mentz, RJ; Kaski, J-C; Dan, G-A; Goldstein, S; Stockbridge, N; Alonso-Garcia, A; Ruilope, LM; Martinez, FA; Zannad, F; Pitt, B; Fiuzat, M; O'Connor, CM

Published Date

  • September 2012

Published In

Volume / Issue

  • 164 / 3

Start / End Page

  • 303 - 312

PubMed ID

  • 22980295

Pubmed Central ID

  • 22980295

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2012.06.006


  • eng

Conference Location

  • United States