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Stopping Trials Early for Benefit-Not So Fast! (November).
Ann Pharmacother. 2012 Nov 7;
Authors: Faust AC, Chung T, Feldman M
Abstract
On October 25, 2011, Eli Lilly and Company announced the voluntary withdrawal of Xigris (drotrecogin alfa [activated]) following the negative results of its most recent clinical trial, the PROWESS-SHOCK study. The purpose of this commentary is to briefly review the history of drotrecogin alfa, discuss issues surrounding early cessation of clinical trials for benefit, and highlight the scientific and ethical dilemmas faced when deciding whether or not to stop a trial early for benefit. This review should serve as an introduction to the topic of stopping trials early for benefit.
PMID: 23136354 [PubMed - as supplied by publisher]