title: 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.affiliation: National Cancer Institute, NIH, Bethesda, MD 20892, USA.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Gutierrez
authors.forename: Shivaani
authors.initials: S
authors.lastname: Kummar
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giaccone
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D004354:Drug Screening Assays, Antitumor; D006801:Humans; D020714:Maximum Tolerated Dose; D008495:Medical Oncology / Q000379:methods; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents