Statistical monitoring of clinical trials : a unified approach / Michael A. Proschan, K.K. Gordan Lan, Janet Turk Wittes.

Author
Proschan, Michael A. [Browse]
Format
Book
Language
English
Published/​Created
New York, NY : Springer, c2006.
Description
xiii, 258 p. : ill. ; 24 cm.

Details

Related name
Series
Statistics for biology and health. [More in this series]
Summary note
"The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") irrespective of the test statistic. The so-called B-value approach to monitoring allows us to use, for different types of trials, the same boundaries and the same simple formula for computing conditional power. Although Brownian motion may sound complicated, the authors make the approach easy by starting with a simple example and building on it, one piece at a time, ultimately showing that Brownian motion works for many different types of clinical trials."--BOOK JACKET.
Bibliographic references
Includes bibliographical references (p. [247]-254) and index.
Contents
1. Introduction -- 2. A general framework -- 3. Power : conditional, unconditional, and predictive -- 4. Historical monitoring boundaries -- 5. Spending functions -- 6. Practical survival monitoring -- 7. Inference following a group-sequential trail -- 8. Options when Brownian motion does not hold -- 9. Monitoring for safety -- 10. Bayesian monitoring -- 11. Adaptive sample size methods -- 12. Topics not covered -- 13. Appendix I : the logrank and related tests -- 14. Appendix II : group-sequential software.
ISBN
0387300597
OCLC
71228590
International Article Number
  • 9780387300597
RCP
C - S