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(Circulation. 2005;112:3654-3666.)
© 2005 American Heart Association, Inc.

Controversies in Cardiovascular Medicine

Should ethnicity serve as the basis for clinical trial design?

Importance of Race/Ethnicity in Clinical Trials

Lessons From the African-American Heart Failure Trial (A-HeFT), the African-American Study of Kidney Disease and Hypertension (AASK), and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Anne L. Taylor, MD; Jackson T. Wright, Jr, PhD, MD

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
The United States has the most affluent and sophisticated medical community in the world, yet large population differences in healthcare outcomes among racial/ethnic populations remain an imposing challenge for the twenty-first century. Although causes of healthcare disparities are many,^1–4 a significant contributor is the absence of research to clearly identify the sources of differences in outcomes in racial/ethnic groups and to distinguish among biological, environmental, or social causes of disease differences.¹ Evaluation of disease differences in subsegments of the population is essential to understand the variety of mechanisms of pathophysiology, as well as to optimally target therapeutic responses. Thus, effective research that would contribute to a reduction in healthcare disparities requires collection of data on health status in racial and ethnic populations and assessment of differences in disease patterns. It also requires clinical trials with the inclusion of adequate numbers of diverse populations to probe for differences in pathophysiology (including environmental or social factors contributing to disease), and responses to treatment. Finally, where differences are observed among population segments, clinical trials focused in these population groups are essential.^1–4

The recently completed African-American Heart Failure Trial (A-HeFT)⁵ and the African-American Study of Kidney Disease and Hypertension (AASK)⁶ are examples of studies focused in ethnic minorities that demonstrate the value of this research approach. In addition, the more than 40 000-participant Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)^7–9 is an example of a clinical trial designed to prospectively assess ethnic differences in response to antihypertensive therapy. Each study has . . . [Full Text of this Article]

Richard S. Cooper, MD; Bruce M. Psaty, MD, PhD

Anne L. Taylor, MD; Jackson T. Wright, Jr, MD, PhD

Richard S. Cooper, MD; Bruce M. Psaty, MD, PhD

Correspondence to Anne L. Taylor, MD, Professor of Medicine/Cardiology, Associate Dean for Faculty Affairs, Co-Director, University of Minnesota National Center of Excellence in Women’s Health, University of Minnesota Medical School, Mayo Mail Code 293, 420 Delaware St SE, Minneapolis, MN 55455 (e-mail taylo135@umn.edu); or Richard S. Cooper, MD, Department of Preventive Medicine and Epidemiology, Loyola Stritch School of Medicine, 2160 S First Ave, Maywood, IL 60153 (e-mail rcooper@lumc.edu).

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