Premature Discontinuation Of Clinical Trial For Reasons Not Related To Efficacy, Safety, Or Feasibility

• Published in: BMJ (Online) 2001-03, Vol.322 (7286), p.603-605
• Main Authors: Lièvre, Michel, Ménard, Joël, Bruckert, Eric, Cogneau, Joël, Delahaye, François, Giral, Philippe, Leitersdorf, Eran, Luc, Gérald, Masana, Luis, Moulin, Philippe, Passa, Philippe, Pouchain, Denis, Siest, Gérard
• Format: Article
• Language: English
• Subjects: Bioethics; Blood; Cholesterol; Clinical trials; Clinical Trials as Topic - economics; Clinical Trials Data Monitoring Committees; College faculty; Committee Membership; Communities; Discontinued; Drug Industry; Education And Debate; Efficacy; Elderly people; Ethics, Medical; Experimentation; Feasibility; Fees; Financing; Humans; Men; Older adults; Primary prevention; Randomized controlled trials; Reasons; Reduction; Research Design; Research Support as Topic; Safety; Social Responsibility; Sponsorship; Statins; Steering
• ISSN: 0959-8138; 0959-535X; 1756-1833; 1468-5833
• DOI: 10.1136/bmj.322.7286.603

When investigators embark on a clinical trial, they naturally expect that the journey will end with the completion of the scheduled patient follow up and publication of the results. Some trials may sink en route because of organisational or ethical reasons, and such misfortunes must be accepted. Sometimes, however, trials are scuttled by their sponsors. Such premature discontinuation not only is frustrating for investigators but may have important medical implications. In this article we analyse the case of a clinical trial that was recently stopped for financial reasons, discuss the consequences of such discontinuations, and make some proposals to avoid recurrence.