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Design and conduct of phase II studies of targeted anticancer therapy: Recommendations from the task force on methodology for the development of innovative cancer therapies (MDICT)

Lookup NU author(s): Professor Alan Calvert

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Abstract

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 endpoints 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. © 2007 Elsevier Ltd. All rights reserved.

Publication metadata

Author(s): Booth C, Calvert AH, Giaccone G, Lobbezoo M, Eisenhauer E, Seymour L

Publication type: Article

Publication status: Published

Journal: European Journal of Cancer

Year: 2008

Volume: 44

Issue: 1

Pages: 25-29

ISSN (print): 0959-8049

ISSN (electronic): 1879-0852

Publisher: Pergamon

URL: http://dx.doi.org/10.1016/j.ejca.2007.07.031

DOI: 10.1016/j.ejca.2007.07.031

PubMed id: 17845846

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