Early stopping of clinical trials: Charting the ethical terrain
2011 (English)In: Kennedy Institute of Ethics journal (Print), ISSN 1054-6863, E-ISSN 1086-3249, Vol. 21, no 1, 57-78 p.Article in journal (Refereed) Published
The decision to terminate a clinical trial earlier than planned isoften described as ethically problematic, but it is rarely systematically analyzedas an ethical issue in its own right. This paper provides an overview of the mainethical considerations at stake in such decisions and of the main tensions betweenthese considerations. Arguments about informed consent and the impact of earlystopping on research and society are explored. We devote particular attentionto a familiar conflict that arises with special urgency when early data suggestthat the experimental treatment is superior. Should the trial be stopped so thatparticipants in the control group will not be allocated a seemingly inferior treatment,or should it continue in pursuit of evidence conclusive enough to improvethe care of future patients? We scrutinize three ways to address this problem.Rather than dissolving the tension, they represent different trade-offs betweenthe respective welfare interests of subjects and future patients.
Place, publisher, year, edition, pages
Johns Hopkins University Press, 2011. Vol. 21, no 1, 57-78 p.
IdentifiersURN: urn:nbn:se:liu:diva-77939DOI: 10.1353/ken.2011.0002OAI: oai:DiVA.org:liu-77939DiVA: diva2:530000