Skip to main content
Log in

Application of Adaptive Interim Analysis in Pharmacology

  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

A Drug Information Association Workshop on “Statistical Methodology on Non-Clinical and Toxicological Studies” was held March 25–27, 1996. The purpose of this meeting was to discuss the appropriateness of current and new biostatistical methods in this field of drug development. This paper describes the application of adaptive interim analysis in pharmacological studies. Bauer and Könne (1) published a two-step approach in the case of unknown a priori information. This approach is now widely used for clinical trails. Here, the advantages of use in some pharmacological studies will be discussed.

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

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994;50: 1029–1041.

    Article  CAS  Google Scholar 

  2. Gould LA. Planning and revising the sample size for a trial. Stat Med. 1995;14:1039–1051.

    Article  CAS  Google Scholar 

  3. Banik N, et al. On the power of Fisher’s combination test for two stage sampling in the presence of nuisance parameters. Biometrical J. 1996;38:25–38.

    Article  Google Scholar 

  4. Bauer P, Röhmel J. An adaptive method for establishing a dose-response relationship. Stat Med. 1995; 14:1595–1607.

    Article  CAS  Google Scholar 

  5. Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics. 1995;51:1315–1324.

    Article  CAS  Google Scholar 

  6. Martin U, Kohnert U, et al. Effective thrombolysis by a recombinant Escherichia Coli produced protease domain of tissue-type plasminogen activator in the rabbit model of jugular vein thrombolysis. Fibrinolysis. 1996;10:87–92.

    Article  CAS  Google Scholar 

  7. Mehta C, Patel N. StatXact 3 for Windows, Cytel Software Corp, Cambridge; 1995.

    Google Scholar 

  8. Noether GE. Sample size determination for some common nonparametric tests. J Am Stat Assoc. 1987; 82:645–647.

    Article  Google Scholar 

  9. Schlag G, Redl H, Khakpour Z, Davies J, Pretorius J. Hypovolemic-traumatic shock models in baboons. I: Schlag, G. and Redl. H. (eds.). Pathophysiology of shock, sepsis and organ failure. Berlin: Springer Verlag Berlin; 1993.

    Chapter  Google Scholar 

  10. O’Brien PC. Procedures for comparing samples with multiple endpoints. Biometrics. 1984;40:1079–1087.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hothorn, L.A., Martin, U. Application of Adaptive Interim Analysis in Pharmacology. Ther Innov Regul Sci 31, 615–619 (1997). https://doi.org/10.1177/009286159703100229

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286159703100229

Key Words

Navigation