On sample size calculation based on odds ratio in clinical trials.
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.
Wang
Hansheng
H
StatPlus, Inc., Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA. hwang@statplusinc.com
Chow
Shein-Chung
SC
Li
Gang
G
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
D014150:Antipsychotic Agents