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Simple Principles of Clinical Trials Remain Powerful
Robert M. Califf, MD
JAMA. 2005;293:489-491.
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In this issue of JAMA, 2 articles from the Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation (CREATE) greatly enhance the knowledge base for the treatment of acute ST-segment elevation myocardial infarction (STEMI).1-2 Yet, as with all good clinical trials, this study raises new questions and perspectives that deserve further consideration.
The factorial design of the CREATE trial proves 2 points: (1) low-molecular-weight heparin reduces mortality and ischemic events in STEMI and (2) the age-old argument about glucose, insulin, and potassium (GIK) therapy can be put to restthis treatment does not work in STEMI. The CREATE trial is powerful and definitive on both counts. However, the conduct and results of the trial stimulate thoughts about several questions.
Do the Principles of Pragmatic Clinical Trials3-4 Still Hold in This Era of "Personalized Medicine"? Despite ongoing efforts to develop more targeted approaches . . . [Full Text of this Article]
Author Affiliations: Duke Clinical Research Institute, Durham, NC.
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