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(Circulation. 2004;110:3610-3614.)
© 2004 American Heart Association, Inc.

Special Report

Lessons Learned From a Clinical Trial

Paul W. Armstrong, MD; L. Kristin Newby, MD, MHS; Christopher B. Granger, MD; Kerry L. Lee, PhD; R. John Simes, MD; Frans Van de Werf, MD, PhD; Harvey D. White, DSc; Robert M. Califf, MD, for the Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (VIGOUR) Group

From the University of Alberta, Edmonton, Alberta, Canada (P.W.A.); Duke Clinical Research Institute, Durham, NC (L.K.N., C.B.G., K.L.L., R.M.C.); National Health & Medical Research Council, Sydney, Australia (R.J.S.); University Hospital Gasthuisberg, Gasthuisberg, Belgium (F.V.d.W.); and Auckland City Hospital, Auckland, New Zealand (H.D.W.).

Correspondence to Paul W. Armstrong, MD, Department of Medicine, 2–51 Medical Sciences Bldg, University of Alberta, Edmonton, Alberta, Canada T6G 2H7. E-mail paul.armstrong@ualberta.ca

Received May 18, 2004; revision received June 21, 2004; accepted August 4, 2004.

Key Words: trials, clinical • multicenter studies • biomedical research • ethics, research

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

	Introduction

 
Remarkable advances in cardiovascular care have been substantially mediated by large-scale, randomized clinical trials. These trials not only have identified treatments resulting in major improvements in patient outcomes but also have enhanced our understanding of the natural history of contemporary disease and the impact of risk factors and complications.

The process by which phase III clinical trials in cardiovascular medicine are created, implemented, completed, analyzed, presented, and published has evolved dramatically over the past decade. Historically, government and academic alliances took center stage in this process because of their intellectual equity, opinion leadership, access to patients, and allocation of public interest–related research tax dollars. This axis has now shifted. Community practitioners and groups of physicians, often organized regionally, now provide the majority of subjects for clinical trials. Furthermore, substantial scientific expertise, at both the basic and clinical levels, resides within multinational pharmaceutical firms. Additionally, contract research organizations have seized the business opportunity afforded by the need for timely and efficient operational aspects of clinical trials. Although community-based trials, efficiency, and expertise are prerequisites for a major clinical trial, the extraordinary costs of completing them squarely places the sponsor in a dominant position.¹

Our participation in the failed large-scale attempt to develop a novel oral glycoprotein IIb/IIIa inhibitor, sibrafiban, for secondary prevention of coronary heart disease has stimulated us to reflect on issues that arose in the design and conduct of this trial.^2,3 Using the Sibrafiban Versus Aspirin to Yield Maximum Protection From ischemic Heart Events Post-Acute Coronary Syndromes (SYMPHONY) and . . . [Full Text of this Article]

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				D. B. Mark, F. J. Van de Werf, R. J. Simes, H. D. White, L. C. Wallentin, R. M. Califf, P. W. Armstrong, and for the VIGOUR Group Cardiovascular disease on a global scale: defining the path forward for research and practice Eur. Heart J., November 1, 2007; 28(21): 2678 - 2684. [Abstract] [Full Text] [PDF]

				C. C. Nessel, P. W. Armstrong, L. K. Newby, C. B. Granger, K. L. Lee, R. M. Califf, R. J. Simes, F. Van de Werf, and H. D. White Letter Regarding Article by Armstrong et al, "Lessons Learned From a Clinical Trial" Circulation, June 14, 2005; 111(23): e393 - e393. [Full Text] [PDF]