Coordinating Clinical Trials to Confirm Drug Safety and Efficacy—Resolving Uncertainty
Abstract
Clinical Review & Education Review Assessment of Pregabalin Postapproval Trials and the Suggestion for Efficacy in New Indications Editor's Note Coordinating Clinical Trials to Confirm Drug Safety and Efficacy—Resolving Uncertainty Joseph S. Ross, MD, MHS Howdoweknow whether a drug works? In the United States, trials,74%wereconsideredexploratoryand26%werepotentially the US Food and Drug Administration (FDA) has established...