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)
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- 作者：Christopher M. Booth ; A. Hilary Calvert ; Giuseppe Giaccone ; Marinus W. Lobbezoo ; Elizabeth A. Eisenhauer ; Lesley K. Seymour
- 关键词：Clinical trials/phase II ; Drug therapy ; Neoplasms ; Receptors ; Growth factors/antagonists ; Inhibitors
- 刊名：European Journal of Cancer
- 出版年：2008
- 出版时间：January 2008
- 年：2008
- 卷：44
- 期：1
- 页码：25-29
- 全文大小：173 K
文摘
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.