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(Circulation. 2002;106:746.)
© 2002 American Heart Association, Inc.

Clinical Cardiology: New Frontiers

Lessons Learned From Recent Cardiovascular Clinical Trials: Part I

David L. DeMets, PhD; Robert M. Califf, MD

From the Duke Clinical Research Institute (R.M.C.), Duke University Medical Center, Durham, NC, and the Department of Biostatistics and Medical Informatics (D.L.D.), University of Wisconsin, Madison, Wis.

Correspondence to Robert M. Califf, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.

Key Words: trials • cardiovascular diseases • therapy • outcome assessment • statistics

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

	Introduction

 
This is the first installment in a 4-part series of articles about our experiences with cardiovascular clinical research during the past 2 decades. From our vantage points as statistical and clinical researchers, we derive a series of lessons from recent clinical trials and incorporate them into principles designed to guide the practicing clinician who cares for patients with heart diseases.

We are entering an era in which the imperative to understand the rational basis for diagnostic and therapeutic options has become a major force in medical care. Medical products (drugs, devices, and biologics) are proliferating simultaneously with a substantial restructuring of the delivery of health care, with a focus on evidence to support medical interventions. As the texture of evidence to support clinical practice becomes clearer, the imperative to investigate the effectiveness of behavioral interventions becomes more important. When coupled with concern about the rising cost of medical care, this proliferation of technological and behavioral intervention reinforces the view that we cannot afford to offer all possible diagnostic and therapeutic options to all patients. Recent publicity about therapies that were in widespread use and were later found to be detrimental^1–3 has fueled this concern to extend well beyond the cost implications. The advent of genomics, proteomics, combinatorial chemistry, and advanced biomedical engineering will increase the importance of developing rational evidence about therapeutic risks and benefits. This effort to develop a rational basis for diagnostic and therapeutic decisions on the basis of quantitative assessments is a major component of evidence-based medicine.

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