Skip to main content

Procedures with Equally Sized Stages

  • Chapter
  • First Online:
  • 2466 Accesses

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

Abstract

In this chapter, we describe group sequential test procedures that are designed for equal sample sizes per stage of the group sequential trial. The procedures that were originally developed in the literature (which we refer to as classical group sequential designs) make this assumption. In practice, the situation with equally sized stages often occurs. Namely, in all cases when there is no specific reason for assuming different stage sizes the sample sizes per stage should be the same.We introduce the designs due to O’Brien and Fleming (Biometrics 35:549–556, 1979), Pocock (Biometrika 64:191–199, 1977) and the power family of Wang and Tsiatis (Biometrics 43:193–199) and describe their basic properties. We also introduce the Pampallona and Tsiatis (Journal of Statistical Planning and Inference 42:19–35, 1994)symmetric design. The one-sided testing in group sequential designs is then described, together with a discussion of the stopping for futility issue in sequential designs. A note on two-sided tests in group sequential designs finalizes the chapter.

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   119.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   159.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   159.99
Price excludes VAT (USA)
  • Durable hardcover 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

  • Anderson, K. M. (2007). Optimal spending functions for asymmetric group sequential designs. Biometrical Journal, 49, 337–345.

    Article  MathSciNet  Google Scholar 

  • Barber, S., & Jennison, C. (2002). Optimal asymmetric one-sided group sequential tests. Biometrika, 89, 49–60.

    Article  MathSciNet  MATH  Google Scholar 

  • DeMets, D. L., & Ware, J. H. (1980). Group sequential methods for clinical trials with a one-sided hypothesis. Biometrika, 67, 651–660.

    Article  MathSciNet  Google Scholar 

  • DeMets, D. L., & Ware, J. H. (1982). Asymmetric group sequential boundaries for monitoring clinical trials. Biometrika, 69, 661–663.

    Article  Google Scholar 

  • Eales, J. D., & Jennison, C. (1992). An improved method for deriving optimal one-sided group sequential tests. Biometrika, 79, 13–24.

    Article  MathSciNet  MATH  Google Scholar 

  • Emerson, S. S., & Fleming, T. R. (1989). Symmetric group sequential test designs. Biometrics, 45, 905–923.

    Article  MathSciNet  MATH  Google Scholar 

  • Gould, A. L., & Pecore, V. J. (1982). Group sequential methods for clinical trials allowing early acceptance of H0 and incorporating costs. Biometrika, 69, 75–80.

    Google Scholar 

  • Haybittle, J. L. (1971). Repeated assessments of results in clinical trials of cancer treatment. British Journal Radiology, 44, 793–797.

    Article  Google Scholar 

  • Jennison, C. (1987). Efficient group sequential tests with unpredictable group sizes. Biometrika, 74, 155–165.

    Article  MathSciNet  MATH  Google Scholar 

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

    MATH  Google Scholar 

  • Köpcke, W. (1984). Zwischenauswertungen und vorzeitiger Abbruch von Therapiestudien. Berlin: Springer.

    Book  Google Scholar 

  • Köpcke, W. (1989). Analyses of group sequential clinical trials. Controlled Clinical Trials, 10, 222–230.

    Article  Google Scholar 

  • McPherson, K. (1982). On choosing the number of interim analyses in clinical trials. Statistics in Medicine, 1, 25–36.

    Article  Google Scholar 

  • O’Brien, P. C. (1998). Data and safety monitoring. In P. Armitage & T. Colton (Eds.), Encyclopedia of biostatistics (pp. 1058–1066). Chichester: Wiley.

    Google Scholar 

  • O’Brien, P. C., & Fleming, T. R. (1979). A multiple testing procedure for clinical trials. Biometrics, 35, 549–556.

    Article  Google Scholar 

  • Pampallona, S., & Tsiatis, A. A. (1994). Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favor of the null hypothesis. Journal of Statistical Planning and Inference, 42, 19–35.

    Article  MathSciNet  MATH  Google Scholar 

  • Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., & Smith, P. G. (1976). Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. British Journal of Cancer, 34, 585–612.

    Article  Google Scholar 

  • Pocock, S. J. (1977). Group sequential methods in the design and analysis of clinical trials. Biometrika, 64, 191–199.

    Article  Google Scholar 

  • Pocock, S. J. (1982). Interim analyses for randomized clinical trials: The group sequential approach. Biometrics, 38, 153–162.

    Article  Google Scholar 

  • Proschan, M. A. (1999). Properties of spending function boundaries. Biometrika, 86, 466–473.

    Article  MathSciNet  MATH  Google Scholar 

  • Wald, A. (1947). Sequential analysis. New York: Wiley.

    MATH  Google Scholar 

  • Wang, S. K., & Tsiatis, A. A. (1987). Approximately optimal one-parameter boundaries for group sequential trials. Biometrics, 43, 193–199.

    Article  MathSciNet  MATH  Google Scholar 

  • Wassmer, G. (1999c). Statistische Testverfahren für gruppensequentielle und adaptive Pläne in klinischen Studien. Theoretische Konzepte und deren praktische Umsetzung mit SAS. Köln: Verlag Alexander Mönch.

    Google Scholar 

  • Wassmer, G., & Bock, W. (1999). Tables of Δ-class boundaries for group sequential trials. Informatik, Biometrie und Epidemiologie in Medizin und Biologie, 30, 190–194.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Wassmer, G., Brannath, W. (2016). Procedures with Equally Sized Stages. In: Group Sequential and Confirmatory Adaptive Designs in Clinical Trials. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-32562-0_2

Download citation

Publish with us

Policies and ethics