Abstract
In this chapter, we review the Frequentist approach to hypothesis testing and in particular the two-action decision problem. The Frequentist approach to statistical inference involves examining probability via its long-run frequency interpretation. Procedures for assessing evidence and making decisions under the Frequentist approach are calibrated by how they would perform when they are used repeatedly. In the context of drug development, the two actions correspond to progressing or not progressing a drug for further development. These two actions are fundamental to decision-making in drug development.
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Dupont, W. D., & Plummer, W. D., Jr. (1990). Power and sample size calculations: A review and computer program. Controlled Clinical Trials 11(2), 116–128.
Jennison, C., & Turnbull, B. W. (2000). Group sequential methods with applications to clinical trials. Boca Raton: Chapman Hall/CRC Press.
Kirby, S., & Chuang-Stein, C. (2011). Determining sample size for classical designs. In A. Pong & S. Chow (Eds.), Adaptive designs in pharmaceutical and clinical development. Boca Raton: Chapman & Hall/CRC Press.
Lindgren, B. (1993). Statistical theory (4th ed.). Boca Raton: Chapman & Hall/CRC Press.
Miller, I., & Miller, M. (2014). John E. Freund’s mathematical statistics (8th ed.). Harlow: Pearson.
Price, K., & LaVange, L. (2014). Bayesian methods in medical product development and regulatory reviews. Pharmaceutical Statistics, 13(1), 1–2.
U.S. Food and Drug Administration. (2014). Complex issues in developing drugs and biological products for rare diseases and accelerating the development of therapies for pediatric rare diseases including strategic plan: Accelerating the development of therapies for pediatric rare diseases. Retrieved November 15, 2016, from http://www.fda.gov/downloads/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/UCM404104.pdf
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Chuang-Stein, C., Kirby, S. (2017). A Frequentist Decision-Making Framework. In: Quantitative Decisions in Drug Development. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-46076-5_2
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DOI: https://doi.org/10.1007/978-3-319-46076-5_2
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