title: Statistical considerations in the design, conduct and analyses of antiemetic clinical trials. An emerging consensus.
abstract: Various aspects of trial design and planning for clinical testing of antiemetic therapies administered to cancer patients are considered. It is generally felt that a randomized double-blind parallel-arm design is the best. Ways of achieving adequate power of such studies are discussed briefly, as is the need for previous identification of primary and secondary end-points. Finally, summary recommendations are given.
authors.affiliation: University of Rochester Cancer Center, NY, USA.
authors.forename: G R
authors.initials: GR
authors.lastname: Morrow
authors.forename: E
authors.initials: E
authors.lastname: Ballatori
authors.forename: S
authors.initials: S
authors.lastname: Groshen
authors.forename: I
authors.initials: I
authors.lastname: Olver
mesh_terms: D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents