References
- Agresti, A. (1990), Categorical Data Analysis, New York: Wiley.
- Chen, Y.F., Yang, Y., Hung, H. J., Wang, S. J. (2011), “Evaluation of Performance of Some Enrichment Designs dealing with High Placebo Response in Psychiatric Clinical Trials,” Contemporary Clinical Trials, 32, 592–604.
- Doros, G., Pencina, M., Rybin, D., Meisner, A., and Fava, M. (2013), “A Repeated Measures Model for Analysis of Continuous Outcomes in Sequential Parallel Comparison Design Studies,” Statistics in Medicine, 32, 2767–2789.
- Ezzet, F. and Whitehead, J. (1992), “A Random Effects Model For Binary Data From Crossover Clinical Trials,” Applied Statistics, 41, 117–126.
- ——— (1993), “A Random Effects Model For Ordinal Responses From Crossover Clinical Trials,” Statistics in Medicine (Authors’ Reply), 12, 2150–2151.
- Fava, M., Evins, A. E., and Dorer, D. J., and Schoenfeld, D.A. (2003), “The Problem of Placebo Response in Clinical Trials for Psychiatric Disorders: Culprits, Possible Remedies, and a Novel Study Design Approach,” Psychotherapy and Psychosomatics, 72, 115–127.
- Fava, M., Mischoulon, D., Iosifescu, D., Witte, J., Pencina, M., Flynn, M., Harper, L., Levy, M., Rickels, K., and Pollack, M. (2009), “A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) among Depressed Out-Patients with Inadequate Response to Prior ADT (ADAPT-A Study), The 48th Annual Meeting of the American College of Neuropsychopharmacology, December.
- Fava, M., Mischoulon, D., Iosifescu, D., Witte, J., Pencina, M., Flynn, M., Harper, L., Levy, M., Rickels, K., and Pollack, M. (2012), “A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy among Depressed Out-Patients with Inadequate Response to Prior Antidepressant Therapy (ADAPT-A Study),” Psychotherapy and Psychosomatics, 81, 87–97.
- Fleiss, J. J. (1981), Statistical Methods for Rates and Proportions (3rd ed.), New York: Wiley.
- Fleiss, J.J., Levin, B., and Paik, M.C. (2003), Statistical Methods for Rates and Proportions (3rd ed.), New York: Wiley.
- Garrett, A. D. (2003), “Therapeutic Equivalence: Fallacies and Falsification,” Statistics in Medicine, 22, 741–762.
- Huang, X., and Tamura, R. N. (2010), “Comparison of Test Statistics for Sequential Parallel Design,” Statistics in Biopharmaceutical Research, 2, 42–50.
- Ivanova, A., Qaqish, B., and Schoenfeld, D.A. (2011), “Optimality, Sample Size and Power Calculations for the Sequential Parallel Comparison Design,” Statistics in Medicine, 30, 2793–2803.
- Jones, B., and Kenward, M.G. (2014), Design and Analysis of Cross-Over Trials (3rd ed.), Boca Raton, FL: Chapman and Hall/CRC, Taylor and Francis.
- Kenward, M.G., and Jones, B. (1992), “Alternative Approaches to the Analysis of Binary and Categorical Repeated Measurements,” Journal of Biopharmaceutical Statistics, 2, 137–170.
- Liu, J.P., Fan, H.-Y., and Ma, M.-C. (2005), “Tests for Equivalence Based on Odds Ratio For Matched-Pair Design,” Journal of Biopharmaceutical Statistics, 15, 889–901.
- Lui, K.-J. (2004), Statistical Estimation of Epidemiological Risk, New York: Wiley.
- ——— (2016), Crossover Designs, Testing, Estimation and Sample Size, New York: Wiley.
- ——— (2017), “Estimation of the Relative Difference (or Relative Risk Reduction) under the Sequential Parallel Comparison Design,” Statistical Methods in Medical Research, doi: 10.1177/0962280217748486, online Dec. 28.
- Lui, K.-J., and Chang, K.-C. (2011), “Test Non-Inferiority (and Equivalence) Based on the Odds Ratio under a Simple Crossover Trial,” Statistics in Medicine, 30, 1230–1242.
- ——— (2016), “Notes on Testing Noninferiority in Multivariate Binary Data under the Matched-Pair Design,” Statistical Methods in Medical Research, 25, 1272–1289.
- Lui, K.-J., and Lin, C.-D. (2003), “A Revisit on Comparing the Asymptotic Interval Estimators of Odds Ratio in a Single 2 x 2 Table,” Biometrical Journal, 45, 226–237.
- Rousson, V., and Seifert, B. (2008), “A Mixed Approach for Proving Non-inferiority in Clinical Trials with Binary Endpoints,” Biometrical Journal, 50, 190–204.
- SAS Institute Inc. (2009), SAS/STAT 9.2 User's Guide (2nd ed.), Cary, NC: SAS Institute.
- Silverman, R. K., Ivanova, A., and Fine, J. (2018), “Sequential Parallel Comparison Design with Binary and Time to Event Outcomes,” Statistics in Medicine, 37, 1454–1466.
- Tamura, R. N., Huang, X., and Boos, D. D. (2011), “Estimation of Treatment Effect for the Sequential Parallel Design,” Statistics in Medicine, 30, 3496–3506.
- Tu, D. (1998), “On the Use of the Ratio and the Odds Ratio of Cure Rates in Establishing Therapeutic Equivalence of Non-Systemic Drugs with Binary Clinical Endpoints,” Journal of Biopharmaceutical Statistics, 8, 263–282.
- ——— (2003), “Odds Ratio,” in Encyclopedia of Biopharmaceutical Statistics, Chow S. D. (ed.), New York: Taylor and Francis Groups, Dekker, 678–684.
- Woolf, B. (1955), “On Estimating the Relation Between Blood Group and Disease,” Annals of Human Genetics, 19, 251–253.