Stopping Trials Early for Benefit—Not So Fast

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, discu...

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Bibliographic Details
Published in:The Annals of pharmacotherapy 2012-11, Vol.46 (11), p.1564-1567
Main Authors: Faust, Andrew C, Chung, Tammy, Feldman, Mark
Format: Article
Language:English
Subjects:
Anti-Infective Agents - therapeutic use
Biological and medical sciences
Clinical trial. Drug monitoring
General pharmacology
Humans
Medical sciences
Pharmacology. Drug treatments
Protein C - therapeutic use
Randomized Controlled Trials as Topic
Recombinant Proteins - therapeutic use
Sepsis - drug therapy
Treatment Outcome
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Summary: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.
ISSN:1060-0280
1542-6270
DOI:10.1345/aph.1Q780