Journal
EUROPEAN JOURNAL OF CANCER
Volume 44, Issue 1, Pages 25-29Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2007.07.031
Keywords
clinical trials/phase II; drug therapy; neoplasms; receptors; growth factors/antagonists; inhibitors
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The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force considered aspects of the design and conduct of phase II studies for molecular targeted agents during their 2007 meeting. The task force recommended that multinomial end-points and designs should be considered for phase II studies of targeted agents, that both single arm as well as randomised designs remain appropriate in certain settings, and that further assessment of novel endpoints (tumour growth kinetic assessment, biomarker or functional imaging) and designs (randomised discontinuation or Bayesian adaptive design) be encouraged. The MDICT cautioned on the use of small randomised trials which have a number of statistical pitfalls and dangers and strongly encouraged the complete reporting, including negative trials, in the scientific literature. (c) 2007 Elsevier Ltd. All rights reserved.
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