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April 24, 2013

Mega-Randomized Clinical Trials for Blockbuster Drugs

Author Affiliations

Letters Section Editor: Jody W. Zylke, MD, Senior Editor.

Author Affiliations: Department of Epidemiology and Public Health, University of Miami Miller School of Medicine, Miami, Florida (ehecht@med.miami.edu).

JAMA. 2013;309(16):1682-1683. doi:10.1001/jama.2013.2736

To the Editor: Many commonly used medications lack information regarding their adverse effects, effectiveness relative to other treatment options, and mortality benefits. In his Viewpoint, Dr Ioannidis1 suggested requiring pharmaceutical companies to fund mega-randomized clinical trials (RCTs) for medications with more than $1 billion in annual sales, using as an example a trial with 20 000 patients, 4 years of follow-up, and mortality as an outcome.