Skip to main content

A Frequentist Decision-Making Framework

  • Chapter
  • First Online:
  • 1183 Accesses

Part of the book series: Springer Series in Pharmaceutical Statistics ((SSPS))

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.

Those who ignore Statistics are condemned to reinvent it.

Bradley Efron

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   54.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   69.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  • 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.

    Google Scholar 

  • Jennison, C., & Turnbull, B. W. (2000). Group sequential methods with applications to clinical trials. Boca Raton: Chapman Hall/CRC Press.

    MATH  Google Scholar 

  • 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.

    Google Scholar 

  • Lindgren, B. (1993). Statistical theory (4th ed.). Boca Raton: Chapman & Hall/CRC Press.

    MATH  Google Scholar 

  • Miller, I., & Miller, M. (2014). John E. Freund’s mathematical statistics (8th ed.). Harlow: Pearson.

    MATH  Google Scholar 

  • Price, K., & LaVange, L. (2014). Bayesian methods in medical product development and regulatory reviews. Pharmaceutical Statistics, 13(1), 1–2.

    Article  Google Scholar 

  • 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

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2017 Springer International Publishing AG

About this chapter

Cite this chapter

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

Download citation

Publish with us

Policies and ethics