2.50
Hdl Handle:
http://hdl.handle.net/10541/75803
Title:
Early stopping of clinical trials.
Authors:
Cuzick, Jack; Howell, Anthony ( 0000-0002-3879-5991 ) ; Forbes, John F
Abstract:
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.
Affiliation:
Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary, University of London, London, UK. jack.cuzick@cancer.org.uk
Citation:
Early stopping of clinical trials. 2005, 7 (5):181-3 Breast Cancer Res.
Journal:
Breast Cancer Research
Issue Date:
2005
URI:
http://hdl.handle.net/10541/75803
DOI:
10.1186/bcr1280
PubMed ID:
16168134
Type:
Article
Language:
en
ISSN:
1465-542X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorCuzick, Jack-
dc.contributor.authorHowell, Anthony-
dc.contributor.authorForbes, John F-
dc.date.accessioned2009-07-29T11:09:15Z-
dc.date.available2009-07-29T11:09:15Z-
dc.date.issued2005-
dc.identifier.citationEarly stopping of clinical trials. 2005, 7 (5):181-3 Breast Cancer Res.en
dc.identifier.issn1465-542X-
dc.identifier.pmid16168134-
dc.identifier.doi10.1186/bcr1280-
dc.identifier.urihttp://hdl.handle.net/10541/75803-
dc.description.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.en
dc.language.isoenen
dc.subjectBreast Canceren
dc.subject.meshBreast Neoplasms-
dc.subject.meshClinical Trials as Topic-
dc.subject.meshEstrogen Replacement Therapy-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshReproducibility of Results-
dc.subject.meshResearch Design-
dc.subject.meshSafety-
dc.subject.meshTime Factors-
dc.titleEarly stopping of clinical trials.en
dc.typeArticleen
dc.contributor.departmentCancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary, University of London, London, UK. jack.cuzick@cancer.org.uken
dc.identifier.journalBreast Cancer Researchen

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