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Journal of Cardiovascular Pharmacology and Therapeutics
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The Importance of Considering Trial Design When Interpreting Clinical Trial Results

James A. Reiffel

Arrhythmia Service, Cardiology Division, Department of Medicine, Columbia Presbyterian Campus of the NYPresbyterian Hospital, Columbia University, New York, NY

Background: In recent decades, clinical trials have played an increasingly important role in determining how we practice. Trial results proving that a clinical finding poses risk have led to interventions that try to reduce risk. Clinical trials proving that a particular therapy provides better outcome than another therapy have changed the therapies we now use. Unfortunately, the results of clinical trials are too often affected by biases or design issues that may overtly or covertly alter the results or the way they should really be used. In addition, these biases and design and analysis issues are rarely evident in the abstract sections or key figures and tables in the publications reporting the trials, which may be all the busy physician either reads or remembers.

Methods and Materials: This manuscript discusses the issues involved in optimally under standing clinical trial design and interpretation so that practitioners can better understand how to intelligently read and apply trial results to clinical practice.

Conclusions: Clinical trial results can not be properly applied without consideration of trial design features and intertrial comparisons.

Key Words: clinical trials • arrhythmias • antiarrhythmic drugs • implantable cardioverter defi brillators.

Journal of Cardiovascular Pharmacology and Therapeutics, Vol. 5, No. 1, 17-25 (2000)
DOI: 10.1177/107424840000500103


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