Early Stopping of Clinical Trials: Charting the Ethical Terrain

The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main te...

Full description

Saved in:  
Bibliographic Details
Authors: Malmqvist, Erik (Author) ; Juth, Niklas (Author) ; Lynöe, Niels (Author) ; Helgesson, Gert (Author)
Format: Electronic Article
Language:English
Check availability: HBZ Gateway
Journals Online & Print:
Drawer...
Fernleihe:Fernleihe für die Fachinformationsdienste
Published: Johns Hopkins Univ. Press 2011
In: Kennedy Institute of Ethics journal
Year: 2011, Volume: 21, Issue: 1, Pages: 51-78
Online Access: Volltext (lizenzpflichtig)
Volltext (lizenzpflichtig)
Description
Summary:The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients.
ISSN:1086-3249
Contains:Enthalten in: Kennedy Institute of Ethics, Kennedy Institute of Ethics journal
Persistent identifiers:DOI: 10.1353/ken.2011.0002