Next generation oncology drug development: Opportunities and challenges

Martin E. Gutierrez, Shivaani Kummar, Giuseppe Giaccone

Research output: Contribution to journalReview articlepeer-review

59 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)259-265
Number of pages7
JournalNature Reviews Clinical Oncology
Issue number5
StatePublished - 2009
Externally publishedYes

ASJC Scopus subject areas

  • Oncology


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