title: Novel agents: clinical trial design.
abstract: The development of molecularly targeted anticancer agents has become an attractive therapeutic strategy. However, evaluation of these novel drugs poses special challenges to laboratory and clinical scientists. These include the creation of appropriate models to assess the effect of the agent on its putative target, the validation of new surrogate endpoints, and the use of effective clinical trial designs. An overview of the difficulties in using a new paradigm of drug development for these target-directed compounds is presented and optimal clinical research methodology to determine their efficacy described.
authors.affiliation: Cancer Therapeutics Branch, National Cancer Institute, Bethesda, MD 20889, USA.
authors.forename: A R
authors.initials: AR
authors.lastname: Tan
authors.forename: S M
authors.initials: SM
authors.lastname: Swain
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D015507:Drugs, Investigational; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D015316:Genetic Therapy; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational; D004791:Enzyme Inhibitors