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2017 | OriginalPaper | Chapter

10. Data Analysis of Dose-Ranging Trials for Binary Outcomes

Authors : Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

Published in: Phase II Clinical Development of New Drugs

Publisher: Springer Singapore

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Abstract

Continuing the data analysis for dose-ranging clinical trials from Chap. 9 for continuous outcomes, we illustrate the analysis for binary data in this chapter. We will use the same data from Chap. 9, but dichotomize the continuous response data into binary data simply for the pedagogical purpose of continuing from the previous chapter and illustrating the methods on analyzing dose-ranging clinical trial with binary data.

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Literature
go back to reference Agresti, A. (2012). Categorical data analysis (3rd ed.). New York: Wiley.MATH Agresti, A. (2012). Categorical data analysis (3rd ed.). New York: Wiley.MATH
go back to reference Armitage, P. (1955). Tests for linear trends in proportions and frequencies. Biometrics, 11(3), 375–386.CrossRef Armitage, P. (1955). Tests for linear trends in proportions and frequencies. Biometrics, 11(3), 375–386.CrossRef
go back to reference Bauer, P., & Budde, M. (1994). Multiple testing for detecting efficient dose steps. Biometrical Journal, 36, 3–15.MATH Bauer, P., & Budde, M. (1994). Multiple testing for detecting efficient dose steps. Biometrical Journal, 36, 3–15.MATH
go back to reference Bauer, P., Rohmel, J., Maurer, W., & Hothorn, L. (1998). Testing strategies in multi-dose experiments including active control. Statistics in Medicine, 17, 2133–2146.CrossRef Bauer, P., Rohmel, J., Maurer, W., & Hothorn, L. (1998). Testing strategies in multi-dose experiments including active control. Statistics in Medicine, 17, 2133–2146.CrossRef
go back to reference Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738–748. Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738–748.
go back to reference Chen, D. G., & Peace, K. E. (2011). Clinical trial data analysis using R. Boca Raton, FL: Chapman and Hall/CRC Biostatistics Series. Chen, D. G., & Peace, K. E. (2011). Clinical trial data analysis using R. Boca Raton, FL: Chapman and Hall/CRC Biostatistics Series.
go back to reference Chen, D. G., Peace, K. E., & Zhang, P. (2017). Clinical trial data analysis using R and SAS (2nd ed.). Boca Raton, FL: Chapman and Hall/CRC Biostatistics Series. Chen, D. G., Peace, K. E., & Zhang, P. (2017). Clinical trial data analysis using R and SAS (2nd ed.). Boca Raton, FL: Chapman and Hall/CRC Biostatistics Series.
go back to reference Chuang-Stein, C., & Li, Z. (2006). Analysis of dose response relationship based on categorical outcomes. In Ting, N. (Ed.), Dose finding in drug development (Chap. 13, pp. 200–219). Berlin: Springer. Chuang-Stein, C., & Li, Z. (2006). Analysis of dose response relationship based on categorical outcomes. In Ting, N. (Ed.), Dose finding in drug development (Chap. 13, pp. 200–219). Berlin: Springer.
go back to reference Dunnett, C. W. (1955). A multiple comparison procedure for comparing several treatments with a control. Journal of the American Statistical Association, 50, 1096–1121.CrossRefMATH Dunnett, C. W. (1955). A multiple comparison procedure for comparing several treatments with a control. Journal of the American Statistical Association, 50, 1096–1121.CrossRefMATH
go back to reference Lewis, J. A. (2004). In defence of the dichotomy. Pharmaceutical Statistics, 3(2), 77–79. Lewis, J. A. (2004). In defence of the dichotomy. Pharmaceutical Statistics, 3(2), 77–79.
go back to reference MacCallum, R. C., Zhang, S., Preacher, K. J., & Rucker, D. D. (2002). On the practice of dichotomization of quantitative variables. Psychological Methods, 7(1), 19–40.CrossRef MacCallum, R. C., Zhang, S., Preacher, K. J., & Rucker, D. D. (2002). On the practice of dichotomization of quantitative variables. Psychological Methods, 7(1), 19–40.CrossRef
go back to reference McCullagh, P. (1980). Regression model for ordinal data (with discussion). Journal of the Royal Statistical Society: Series B, 42, 109–142.MATHMathSciNet McCullagh, P. (1980). Regression model for ordinal data (with discussion). Journal of the Royal Statistical Society: Series B, 42, 109–142.MATHMathSciNet
go back to reference Newcombe, R. G. (1998a). Two-sided confidence intervals for the single proportion: Comparison of seven methods. Statistics in Medicine, 17, 857–872.CrossRef Newcombe, R. G. (1998a). Two-sided confidence intervals for the single proportion: Comparison of seven methods. Statistics in Medicine, 17, 857–872.CrossRef
go back to reference Newcombe, R. G. (1998b). Interval estimation for the difference between independent proportions: Comparison of eleven methods. Statistics in Medicine, 17, 873–890.CrossRef Newcombe, R. G. (1998b). Interval estimation for the difference between independent proportions: Comparison of eleven methods. Statistics in Medicine, 17, 873–890.CrossRef
go back to reference Pearson, K. (1900). On the criterion that a given system of deviations from the probable in the case of a correlated system of variables is such that it can be reasonably supposed to have arisen from random sampling. Philosophical Magazine Series 5 50(302), 157–175. Pearson, K. (1900). On the criterion that a given system of deviations from the probable in the case of a correlated system of variables is such that it can be reasonably supposed to have arisen from random sampling. Philosophical Magazine Series 5 50(302), 157–175.
go back to reference Snapinn, S. M., & Jiang, Q. (2007). Responder analysis and the assessment of a clinically relevant treatment effect. Trials, 8(31), 1–6. Snapinn, S. M., & Jiang, Q. (2007). Responder analysis and the assessment of a clinically relevant treatment effect. Trials, 8(31), 1–6.
go back to reference Uryniak, T., Chan, I. S. F., Fedorov, V. V., Jiang, Q., Oppenheimer, L., Snapinn, S. W., et al. (2012). Responder analysis-A PhRMA position paper. Statistics in Biopharmaceutical Research, 3(3), 476–487.CrossRef Uryniak, T., Chan, I. S. F., Fedorov, V. V., Jiang, Q., Oppenheimer, L., Snapinn, S. W., et al. (2012). Responder analysis-A PhRMA position paper. Statistics in Biopharmaceutical Research, 3(3), 476–487.CrossRef
go back to reference Wilson, E. B. (1927). Probable inference, the law of succession, and statistical inference. Journal of American Statistical Association, 22, 209–212.CrossRef Wilson, E. B. (1927). Probable inference, the law of succession, and statistical inference. Journal of American Statistical Association, 22, 209–212.CrossRef
Metadata
Title
Data Analysis of Dose-Ranging Trials for Binary Outcomes
Authors
Naitee Ting
Ding-Geng Chen
Shuyen Ho
Joseph C. Cappelleri
Copyright Year
2017
Publisher
Springer Singapore
DOI
https://doi.org/10.1007/978-981-10-4194-5_10

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