- Title
- Early stopping of clinical trials (Commentary)
- Creator
- Cuzick, J; Howell, A; Forbes, John
- Relation
- Breast Cancer Research Vol. 7, no. 5, p. 181-183
- Publisher
- M. Nijhoff
- Resource Type
- journal article
- Date
- 2005
- 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.
- Subject
- breast-cancer; postmenopausal women; randomized-trial; tamoxifen; therapy; prevention
- Identifier
- uon:165
- Identifier
- http://hdl.handle.net/1959.13/25174
- Identifier
- ISSN:0167-6806
- Language
- eng
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