Contents
Series Introduction iii
Preface v
Contributors ix
Part I METHODS FOR EARLY TRIALS
1. Bayesian Methods for Cancer Phase I Clinical Trials 1
James S. Babb and Andre´ Rogatko
2. Design of Early Trials in Stem Cell Transplantation:
A Hybrid Frequentist-Bayesian Approach 41
Nancy L. Geller, Dean Follmann, Eric S. Leifer, and
Shelly L. Carter
Part II METHODS FOR RANDOMIZED TRIALS
3. Design and Analysis of Therapeutic Equivalence Trials 53
Richard M. Simon
4. Adaptive Two-Stage Clinical Trials 67
Michael A. Proschan
5. Design and Analysis of Cluster Randomization Trials 83
David M. Zucker
vii
6. Design and Analysis of Clinical Trials with Multiple
Endpoints 101
Nancy L. Geller
7. Subgroups and Interactions 121
Dean Follmann
8. A Class of Permutation Tests for Some Two-Sample
Survival Data Problems 141
Joanna H. Shih and Michael P. Fay
9. Bayesian Reporting of Clinical Trials 161
Simon Weeden, Laurence S. Freedman, and Mahesh
Parmar
Part III MORE COMPLEX PROBLEMS
10. Methods Incorporating Compliance in Treatment
Evaluation 189
Juni Palmgren and Els Goetghebeur
11. Analysis of Longitudinal Data with Missingness 213
Paul S. Albert and Margaret C. Wu
12. Statistical Issues Emerging from Clinical Trials in HIV
Infection 237
Abdel G. Babiker and Ann Sarah Walker
Index of Abbreviations 273
Index of Clinical Trials Used as Examples 277
Subject Index 279