6. Monitoring Randomized Clinical Trials

  1. Klaus Hinkelmann
  1. Eric S. Leifer1 and
  2. Nancy L. Geller2

Published Online: 3 JAN 2012

DOI: 10.1002/9781118147634.ch6

Design and Analysis of Experiments: Special Designs and Applications, Volume 3

Design and Analysis of Experiments: Special Designs and Applications, Volume 3

How to Cite

Leifer, E. S. and Geller, N. L. (2012) Monitoring Randomized Clinical Trials, in Design and Analysis of Experiments: Special Designs and Applications, Volume 3 (ed K. Hinkelmann), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118147634.ch6

Editor Information

  1. Virginia Polytechnic Institute and State University, Blacksburg, Virginia, USA

Author Information

  1. 1

    Blood Institute in Bethesda, Maryland, USA

  2. 2

    National Heart, Lung, and Blood Institute in Bethesda, USA

Publication History

  1. Published Online: 3 JAN 2012
  2. Published Print: 27 JAN 2012

Book Series:

  1. Wiley Series in Probability and Statistics

Book Series Editors:

  1. David J. Balding,
  2. Noel A. C. Cressie,
  3. Garrett M. Fitzmaurice,
  4. Harvey Goldstein,
  5. Iain M. Johnstone,
  6. Geert Molenberghs,
  7. David W. Scott,
  8. Adrian F. M. Smith,
  9. Ruey S. Tsay and
  10. Sanford Weisberg

ISBN Information

Print ISBN: 9780470530689

Online ISBN: 9781118147634

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Keywords:

  • randomized clinical trials, conditional, unconditional power;
  • dichotomous outcomes, occurrence (yes/no) of outcome;
  • CAST II trial, and spending functions, flexibility for DSMBs

Summary

This chapter contains sections titled:

  • Introduction

  • Normally Distributed Outcomes

  • Brownian Motion Properties

  • Brief Historical Overview of Group Sequential Methods

  • Dichotomous Outcomes

  • Time-to-Event Outcomes

  • Unconditional Power

  • Conditional Power

  • Spending Functions

  • Flexibility and Properties of Spending Functions

  • Modifying the Trial's Sample Size Based on a Nuisance Parameter

  • Sample Size Modification Based on the Interim Treatment Effect

  • Concluding Remarks

  • References