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(Circulation. 2002;106:1172.)
© 2002 American Heart Association, Inc.

Clinical Cardiology: New Frontiers

Principles From Clinical Trials Relevant to Clinical Practice: Part II

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

From the Duke Clinical Research Institute and the Division of Cardiology (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 last installment of a 4-part series discusses the final 5 of 11 principles derived from clinical trials during the last 2 decades of cardiovascular clinical research and the need to apply them to the care of individual patients with heart diseases.

	Principle 7: Most Therapies Produce a Combination of Helpful and Harmful Effects

 
As therapies have become more biologically potent, it has become increasingly clear that every treatment can be harmful in some patients while being beneficial in others, and often both good and bad effects occur in the same patient. With many therapies, clinical characteristics can identify patients with greater expected benefit or risk, and pharmacogenetics may offer further insight into predicting which patients will achieve the greatest benefit and which will have the greatest risk of harm. For example, we know that women are at higher risk for torsades de pointes when they are treated with QT-interval-prolonging drugs, and it is likely that a genetic predisposition may be important.¹ Unfortunately, however, the relative power of these findings is limited, and we are left with broad treatment guidelines that will leave patients at risk of harm that cannot be predicted in absolute terms.

The recognition that therapeutics are not commonly either "good" or "bad," but carry a mixture of good and bad effects, has spawned the concept of risk-management in therapeutics. Each clinician has the responsibility of helping the patient place these risks and benefits in perspective when making decisions about therapeutics. Inevitably, this approach will require an improved grasp of probabilities and quantitative outcome estimates by clinicians and patients. . . . [Full Text of this Article]

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