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(Circulation. 1998;97:1107.)
© 1998 American Heart Association, Inc.

Cardiovascular News

Cardiovascular News

Paul W. Armstrong, MD; James T. Willerson, MD; ; Dan M. Roden, MD

Clinical Cardiology: New Frontiers

Cardiovascular medicine is undergoing extraordinary and rapid transformation. Circulation intends to keep its readership at the forefront of advances in our knowledge. Hence, in this issue, we introduce a section entitled "Clinical Cardiology: New Frontiers." Approximately once per month, we will engage topics of a clinically relevant nature to integrate new discoveries and knowledge into the armamentarium of the clinical practitioner. We intend that these articles will be helpful in influencing the thinking and clinical practice of physicians. Our primary goal is to provide useful information and practical advice on the management of contemporary clinical problems. Eligible topics will be drawn from a wide range of areas, including pathophysiology, diagnostic methods, epidemiology, natural history, and therapy.

Because we aim to provide mechanistic insights and evaluate areas of controversy and uncertainty, we will generally invite two key opinion leaders to write articles in this section. Readers will note, however, that they will be from different institutions so as to achieve both diversity and balance. We welcome feedback on this new initiative.

Cardiovascular and Renal Advisory Panel of the FDA

The Cardiovascular and Renal Advisory Panel of the FDA met on October 23 and 24, 1997, to discuss the broad issue of evaluation of active-control trials and to consider the platelet antagonist clopidogrel.

Although the traditional basis for drug approval has included demonstration of superiority to placebo in two trials, it is increasingly recognized that under some circumstances, a placebo-controlled trial is not feasible. In a half-day workshop, issues related to conduct and analysis of active-control trials were discussed. Placebo-controlled . . . [Full Text of this Article]

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				D. M. Roden and R. Temple The US Food and Drug Administration Cardiorenal Advisory Panel and the Drug Approval Process Circulation, April 5, 2005; 111(13): 1697 - 1702. [Full Text] [PDF]