Statistical considerations in the design, conduct and analyses of antiemetic clinical trials. An emerging consensus.
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.
Morrow
G R
GR
University of Rochester Cancer Center, NY, USA.
Ballatori
E
E
Groshen
S
S
Olver
I
I
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*
D000932:Antiemetics; D000970:Antineoplastic Agents