title: On sample size calculation based on odds ratio in clinical trials.
abstract: Sample size calculation formulas for testing equality, noninferiority, superiority, and equivalence based on odds ratio were derived under both parallel and one-arm crossover designs. An example concerning the study of odds ratio between a test compound (treatment) and a standard therapy (control) for prevention of relapse in subjects with schizophrenia and schizoaffective disorder is presented to illustrate the derived formulas for sample size calculation for various hypotheses under both a parallel design and a crossover design. Simulations were performed to assess the adequacy of the sample size calculation formulas. Simulation results were given at the end of the paper.
authors.affiliation: StatPlus, Inc., Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA. hwang@statplusinc.com
authors.forename: Hansheng
authors.initials: H
authors.lastname: Wang
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Gang
authors.initials: G
authors.lastname: Li
mesh_terms: D000465:Algorithms; D014150:Antipsychotic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D018592:Cross-Over Studies; D006801:Humans; D016017:Odds Ratio; D011618:Psychotic Disorders / Q000188:drug therapy; D012008:Recurrence; D018570:Risk Assessment; D018401:Sample Size; D012559:Schizophrenia / Q000188:drug therapy
chemical_list: D014150:Antipsychotic Agents