TY - JOUR
T1 - Next generation oncology drug development
T2 - Opportunities and challenges
AU - Gutierrez, Martin E.
AU - Kummar, Shivaani
AU - Giaccone, Giuseppe
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
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U2 - 10.1038/nrclinonc.2009.38
DO - 10.1038/nrclinonc.2009.38
M3 - Review article
C2 - 19390552
AN - SCOPUS:67651216410
SN - 1759-4774
VL - 6
SP - 259
EP - 265
JO - Nature Reviews Clinical Oncology
JF - Nature Reviews Clinical Oncology
IS - 5
ER -