Next generation oncology drug development: opportunities and challenges.

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.

• Authors: Martin E Gutierrez, Shivaani Kummar, Giuseppe Giaccone
• Journal: Nature reviews. Clinical oncology (Nat Rev Clin Oncol) Vol. 6 Issue 5 Pg. 259-65 (May 2009) ISSN: 1759-4782 [Electronic] England
• PMID: 19390552 (Publication Type: Journal Article, Review)

Chemical References

• Antineoplastic Agents

Topics

• Antineoplastic Agents (therapeutic use)
• Clinical Trials as Topic
• Dose-Response Relationship, Drug
• Drug Design
• Drug Screening Assays, Antitumor
• Humans
• Maximum Tolerated Dose
• Medical Oncology (methods)
• Neoplasms (drug therapy)
• Patient Selection
• Research Design