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[Phases 0, 1 and 2 oncology clinical trials: current questions].

Authors
  • Penel, N
  • Fournier, C
  • Stéphanie, C
Type
Published Article
Journal
Bulletin du Cancer
Publisher
Elsevier
Publication Date
Jan 01, 2010
Volume
97
Issue
1
Pages
55–63
Identifiers
DOI: 10.1684/bdc.2010.1016
PMID: 20080458
Source
Medline
License
Unknown

Abstract

We propose here a general review of current questions related to early trials, including the choice of the primary endpoint, role of bayesian designs, role of stratification and randomization for phase 2 trials, patient selection, and new designs for phase 1 and phase 0 trials. We also discuss the difficulties to apply such methodologies to molecular targeted therapies development.

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