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Nat Rev Clin Oncol. 2009 May;6(5):259-65. doi: 10.1038/nrclinonc.2009.38.

Next generation oncology drug development: opportunities and challenges.

Author information

1
National Cancer Institute, NIH, Bethesda, MD 20892, USA.

Abstract

The optimal development of novel molecularly targeted agents for the treatment of cancer requires a re-evaluation of the current drug development paradigm. Selection of patients, optimal biologic dose versus maximum tolerated dose, definition of response and clinical benefit and trial designs that address these considerations are the focus of debate in the field of early cancer therapeutics. We present a review of the opportunities and challenges facing drug development in oncology through the phases of clinical development starting with first-in-human trials.

PMID:
19390552
DOI:
10.1038/nrclinonc.2009.38
[Indexed for MEDLINE]

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