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Clinical Trials—Multiple Treatments, Multiple End Points, and Multiple Lessons
Michael S. Lauer, MD;
Eric J. Topol, MD
JAMA. 2003;289:2575-2577.
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In 1986, the GISSI group1 published a report of a large randomized clinical trial demonstrating that intravenous streptokinase reduces the risk of death among patients with acute myocardial infarction. The design of the trial was simple, as was the published report. There was one treatment, intravenous streptokinase, whereas the control group received no streptokinase. There was no blinding and no placebo. The end point of interest was death from any cause during hospitalization.
Since the publication of the landmark GISSI-1 trial, many more randomized trials have been performed and their results published. However, as noted in 2 articles published in this issue of THE JOURNAL, the nature of clinical trials and their reporting has become more complex. Freemantle and colleagues2 address the issue of trials that focus on composite end points that consist of multiple outcomes, rather than on a single end . . . [Full Text of this Article]
Author Affiliations: Department of Cardiovascular Medicine (Drs Lauer and Topol), Cleveland Clinic Foundation, Cleveland, Ohio; and JAMA (Dr Lauer).
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