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Stopping trials early for benefit--not so fast!
Andrew C Faust1, Tammy Chung, Mark Feldman
1Department of Pharmacy, Texas Health Presbyterian Hospital Dallas. TX, USA. andrewfaust@texashealth.org
The Annals of Pharmacotherapy
|November 9, 2012
Summary
Eli Lilly withdrew Xigris (drotrecogin alfa [activated]) after the PROWESS-SHOCK trial. This commentary reviews drotrecogin alfa history and ethical dilemmas of stopping clinical trials early for benefit.
Area of Science:
- Pharmacology and Clinical Trials
- Medical Ethics
Background:
- Xigris (drotrecogin alfa [activated]) was voluntarily withdrawn by Eli Lilly and Company on October 25, 2011.
- This withdrawal followed negative results from the PROWESS-SHOCK clinical trial.
Purpose of the Study:
- To review the history of drotrecogin alfa (activated).
- To discuss issues concerning the early cessation of clinical trials for benefit.
- To highlight scientific and ethical dilemmas in deciding to stop trials early for benefit.
Main Methods:
- This is a commentary and review, not a primary research study.
- It involves analyzing the history of a specific drug and clinical trial outcomes.
- It discusses ethical considerations in clinical trial management.
Main Results:
- The PROWESS-SHOCK study yielded negative results, leading to Xigris withdrawal.
- The commentary introduces the complexities and ethical considerations of early trial cessation for benefit.
Conclusions:
- Decisions to stop clinical trials early for benefit involve significant scientific and ethical challenges.
- Understanding these dilemmas is crucial for future clinical trial conduct and drug development.
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