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Early stopping of randomized clinical trials for overt efficacy is problematic

Bassler, D. and Montori, V. M. and Briel, M. and Glasziou, P. and Guyatt, G.. (2008) Early stopping of randomized clinical trials for overt efficacy is problematic. Journal of clinical epidemiology, Vol. 61, H. 3. pp. 241-246.

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Official URL: http://edoc.unibas.ch/dok/A6007441

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Abstract

OBJECTIVE: To illustrate controversial issues associated with stopping randomized controlled trials (RCTs) early for apparent benefit. STUDY DESIGN AND SETTING: The article presents our review of prior relevant work and our research group's reflections on early stopping. RESULTS: Compelling evidence suggests that trials stopped early for benefit systematically overestimate treatment effects, sometimes by a large amount. Unresolved controversies in trials stopped early for benefit include ethical and statistical problems in the interpretation of results. CONCLUSIONS: The best strategy to minimize the problems associated with early stopping of RCTs for benefit is not to stop early. As an alternative, we suggest a threefold approach: a low P-value as the threshold for stopping at the time of interim analyses, not to look before a sufficiently large number of events has accrued and continuation of enrollment and follow-up for a further period.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
UniBasel Contributors:Briel, Matthias
Item Type:Article, refereed
Article Subtype:Further Journal Contribution
Bibsysno:Link to catalogue
Publisher:Pergamon Press
ISSN:0895-4356
Note:Publication type according to Uni Basel Research Database: Journal item
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Last Modified:23 May 2014 08:34
Deposited On:23 May 2014 08:34

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