Please use this identifier to cite or link to this item: http://hdl.handle.net/1959.13/25174

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Title
Early stopping of clinical trials (Commentary)
Author/Creator
Cuzick, J;  Howell, A;  Forbes, John
Description
Early stopping of clinical trials in favour of a new treatment creates ethical and scientific difficulties, which are different from those associated with early stopping due to toxicity or futility. Two major breast cancer trials have recently taken such a decision, and the problem is relevant for several ongoing trials. Here we argue that such a decision should be taken with the utmost gravity and should be based on a clear overall clinical benefit for the new treatment, and not as an automatic response to crossing a predefined threshold. Predefined rules can be used to trigger a debate within the Independent Data Monitoring and Safety Committee (IDMC) about early stopping, but the IDMC should retain the responsibility of assessing overall clinical benefit in making its recommendation.
Relation
Breast Cancer Research Vol. 7, no. 5, p. 181-183
Date
2005
Publisher
M. Nijhoff
Keyword(s)
breast-cancer;  postmenopausal women;  randomized-trial;  tamoxifen;  therapy;  prevention
Resource Type
journal article
Identifier
http://hdl.handle.net/1959.13/25174
Identifier
ISSN:0167-6806
Language
eng
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Subject
"Breast Cancer Research"
 
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