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Martha J. Radford, MD; JoAnne M. Foody, MD

JAMA. 2001;286:1228-1230.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The impressive advances in cardiovascular therapy during the last several decades owe a great deal to randomized trials.¹ The foundation for 21st-century cardiovascular care has been laid, therapy by therapy, through the disciplined application of randomized trial methodology to important scientific insights and therapeutic uncertainties. The random assignment of patients to receive one care strategy or therapy vs another has allowed investigators to separate consistent therapeutic efficacy "signals" from the "noise" of patient variability and physician bias.

Ethical design of randomized trials obligates the investigator to enroll patients with characteristics indicating a relatively high likelihood of benefit and low likelihood of harm from participation in the trial.¹ But how far can the results obtained from the special populations enrolled in trials² be extrapolated to others who would not have been enrolled? Given the delicate balance between risk and benefit of therapy, should . . . [Full Text of this Article]

Author Affiliations: Yale New Haven Health System Center for Outcomes Research and Evaluation (Dr Radford) and Section of Cardiovascular Medicine, Department of Medicine (Drs Radford and Foody), Yale University School of Medicine, New Haven, Conn; Qualidigm, Middletown, Conn (Drs Radford and Foody).

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