title: Design and conduct of phase II studies of targeted anticancer therapy: recommendations from the task force on methodology for the development of innovative cancer therapies (MDICT).
abstract: The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force considered aspects of the design and conduct of phase II studies for molecular targeted agents during their 2007 meeting. The task force recommended that multinomial endpoints and designs should be considered for phase II studies of targeted agents, that both single arm as well as randomised designs remain appropriate in certain settings, and that further assessment of novel endpoints (tumour growth kinetic assessment, biomarker or functional imaging) and designs (randomised discontinuation or Bayesian adaptive design) be encouraged. The MDICT cautioned on the use of small randomised trials which have a number of statistical pitfalls and dangers and strongly encouraged the complete reporting, including negative trials, in the scientific literature.
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, ON, Canada.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Booth
authors.forename: A Hilary
authors.initials: AH
authors.lastname: Calvert
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giaccone
authors.forename: Marinus W
authors.initials: MW
authors.lastname: Lobbezoo
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Eisenhauer
authors.forename: Lesley K
authors.initials: LK
authors.lastname: Seymour
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D015195:Drug Design; D006287:Health Planning Guidelines; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D035703:Therapies, Investigational / Q000379:methods*
chemical_list: D000970:Antineoplastic Agents