title: Choosing phase II endpoints and designs: evaluating the possibilities.
abstract: Selecting the phase II design and endpoint to achieve the best possible chance of success for a confirmatory phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets and from mathematical models can be useful tools for evaluating statistical properties.
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, USA. mleblanc@fhcrc.org
authors.forename: Michael
authors.initials: M
authors.lastname: LeBlanc
authors.forename: Catherine
authors.initials: C
authors.lastname: Tangen
mesh_terms: D001557:Benzenesulfonates / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D000077157:Sorafenib
chemical_list: D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib