Implications of geographical variation on clinical outcomes of cardiovascular trials

被引：43

作者：

Mentz, Robert J. ^{[1
]}

Kaski, Juan-Carlos ^{[2
]}

Dan, Gheorghe-Andrei ^{[3
]}

Goldstein, Sidney ^{[4
]}

Stockbridge, Norman ^{[5
]}

Alonso-Garcia, Angeles ^{[6
]}

Ruilope, Luis M. ^{[7
]}

Martinez, Felipe A. ^{[8
]}

Zannad, Faiez ^{[9
]}

Pitt, Bertram ^{[10
]}

Fiuzat, Mona ^{[1
]}

O'Connor, Christopher M. ^{[1
]}

机构：

[1] Duke Univ, Med Ctr, Durham, NC 27710 USA

[2] Univ London, Cardiovasc Sci Res Ctr, London, England

[3] Univ Med & Pharm Carol Davila, Colentina Univ Hosp, Bucharest, Romania

[4] Henry Ford Hosp, Detroit, MI 48202 USA

[5] US FDA, Div Cardiorenal Drug Prod, Rockville, MD 20857 USA

[6] Hosp Univ Puerta de Hierro, Madrid, Spain

[7] Hosp 12 Octubre, E-28041 Madrid, Spain

[8] Natl Univ Cordoba, Cordoba, Argentina

[9] Ctr Invest Clin, Nancy, France

[10] Univ Michigan, Sch Med, Univ Hosp, Ann Arbor, MI USA

来源：

AMERICAN HEART JOURNAL | 2012年 / 164卷 / 03期

关键词：

ACUTE MYOCARDIAL-INFARCTION; ACUTE CORONARY SYNDROMES; HEART-FAILURE; INTERNATIONAL DIFFERENCES; END-POINTS; MERIT-HF; MANAGEMENT; WARFARIN; GLOBALIZATION; COUNTRIES;

D O I：

10.1016/j.ahj.2012.06.006

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (Am Heart J 2012;164:303-12.)

引用

页码：303 / 312

页数：10

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