Early stopping of clinical trials (Commentary)

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