AffiliationCancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary, University of London, London, UK. email@example.com
MetadataShow full item record
AbstractEarly 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.
CitationEarly stopping of clinical trials. 2005, 7 (5):181-3 Breast Cancer Res.
JournalBreast Cancer Research
- A decision rule for sequential monitoring of clinical trials with a primary and supportive outcome.
- Authors: Zhao Y, Grambsch PM, Neaton JD
- Issue date: 2007
- Stopping clinical trials early for benefit: impact on estimation.
- Authors: Freidlin B, Korn EL
- Issue date: 2009 Apr
- Sequential clinical trials in cancer research.
- Authors: George SL
- Issue date: 1980 Feb-Mar
- Assessment of futility in clinical trials.
- Authors: Snapinn S, Chen MG, Jiang Q, Koutsoukos T
- Issue date: 2006 Oct-Dec
- Data handling in clinical trials: an ongoing debate.
- Authors: Jongen PJ
- Issue date: 1995