Introduction. Single-Arm Phase II Trial Designs. Inference on the Binomial Probability in Single-Arm Multistage Clinical Trials. Single-Arm Phase II Clinical Trials with Time-to-Event Endpoints. Single-Arm Phase II Trials with Heterogeneous Patient Populations: Binary and Survival Outcomes. Randomized Phase II Trials for Selection: No Prospective Control Arms. Randomized Phase II Cancer Clinical Trials with a Prospective Control on Binary Endpoints (I): Two-Sample Binomial Test. Randomized Phase II Cancer Clinical Trials with a Prospective Control on Binary Endpoints (II): Fisher's Exact Test. Randomized Phase II Trials with Heterogeneous Patient Populations: Stratified Fisher's Exact Test. Randomized Phase II Clinical Trials Based on Survival Endpoints: Two-Sample Log-Rank Test. Some Flexible Phase II Clinical Trial Designs. Index.
Sin-Ho Jung is a professor of biostatistics and bioinformatics at Duke University School of Medicine. He earned a PhD from the University of Wisconsin-Madison. His research interests include clinical trial design, survival analysis, longitudinal data analysis, clustered data analysis, ROC curve analysis, and microarray studies.
"Randomized Phase II Cancer Clinical Trials will be an invaluable
source of information and reference for anyone interested in phase
II cancer clinical trials, be it a graduate student, a
biostatistics professor, or a cancer clinician in need of flexible
designs and statistical analyses. … informative and interesting to
read. The first of its kind, this book introduces the recent
development of the promising randomized phase II trials. … This
book has a very coherent structure and a legible style. … The
author did an excellent job providing both contextual and technical
details in a form that is both engaging and very readable. … a
practical guidance book for cancer clinicians, as well as an
excellent reference book for a more broad course, say, for example,
clinical trials."
—Journal of the American Statistical Association, December 2014"…
this book is very timely and it can help biostatisticians and
oncologists design more elaborate cancer clinical trials. This book
is well written and nicely organized to illustrate statistical
concepts and methods in both single-arm and randomized phase II
cancer clinical trials. … This book is certainly one of the best
textbooks for a graduate-level clinical trial course in the
biostatistics department. Also, oncologists with weak statistical
background can easily understand the statistical concepts of the
phase II cancer clinical trials since the author tries to explain
the key concepts with many tables and figures instead of relying on
equations."
—Biometrics, September 2014"… the book is unique in that it focuses
solely on phase II cancer clinical trials with its emphasis on
randomised trials. It goes far beyond what is covered on phase II
clinical trials in cancer in books, for example, in Buyse et al.
(1984) and more recently in Crowley & Hoering (2012) or Green et
al. (2012). As such, it will definitely serve well as a reference
for those involved in phase II cancer c
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