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A Confidence Interval Approach in Self-Designing Clinical Trials

  • Guido KnappEmail author
Conference paper
Part of the Contributions to Statistics book series (CONTRIB.STAT.)

Abstract

In self-designing clinical trials, a special case of adaptive group sequential experiments, a confidence interval for the difference of normal means is derived, in which the results of the respective study stages are combined using the weighted inverse normal method. During the course of the self-designing trial, the sample sizes as well as the number of study stages can be simultaneously determined in a completely adaptive way. Practical rules for updating sample sizes and assigning weights to the study stages are presented. The implementation of the self-designing trial and the resulting confidence interval are demonstrated using real data.

Keywords

Study Stage Equal Sample Size Adaptive Planning Adaptive Group Pivotal Statistic 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

This paper is based on some earlier joint work with Joachim Hartung.

References

  1. 1.
    Brannath, W., Posch, M., Bauer, P.: Recursive combination tests. J. Am. Stat. Assoc. 97, 236–244 (2002)CrossRefzbMATHMathSciNetGoogle Scholar
  2. 2.
    Cheng, Y., Shen, Y.: Estimation of a parameter and its exact confidence interval following sequential sample size reestimation trials. Biometrics 60, 910–918 (2004)CrossRefzbMATHMathSciNetGoogle Scholar
  3. 3.
    EMEA (The European Agency for the Evaluation of Medicinal Products) Points to Consider on Switching between Superiority and Non-inferiority. London, CPMP/EWP/482/99 (2000)Google Scholar
  4. 4.
    Fisher, L.: Self-designing clinical trials. Stat. Med. 17, 1551–1562 (1998)CrossRefGoogle Scholar
  5. 5.
    Hartung, J.: A self-designing rule for clinical trials with arbitrary response variables. Control. Clin. Trials 22, 111–116 (2001)CrossRefGoogle Scholar
  6. 6.
    Hartung, J.: Flexible designs by adaptive plans of generalized Pocock- and O’Brien-Fleming-type and by self-designing clinical trials. Biom. J. 48, 521–536 (2006)CrossRefMathSciNetGoogle Scholar
  7. 7.
    Hartung, J., Knapp, G., Sinha, B.K.: Statistical Meta-Analysis with Applications. Wiley, Hoboken (2008)CrossRefzbMATHGoogle Scholar
  8. 8.
    Lehmacher, W., Wassmer, G.: Adaptive sample size calculations in group sequential trials. Biometrics 55, 1286–1290 (1999)CrossRefzbMATHGoogle Scholar
  9. 9.
    Shen, Y., Fisher, L.: Statistical inference for self-designing clinical trials with a one-sided hypothesis. Biometrics 55, 190–197 (1999)CrossRefzbMATHGoogle Scholar
  10. 10.
    Zhu, H., Hu, F.: Sequential monitoring of response-adaptive randomized clinical trials. Ann. Stat. 38, 2218–2241 (2010)CrossRefzbMATHMathSciNetGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.Department of StatisticsTU Dortmund UniversityDortmundGermany

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