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