1. Introduction, 2. Statistical Concepts, 3. The Design of Clinical Trials, 4. Phase I and Phase I/II Trials, 5. Phase II Trials, 6. Phase III Trials, 7. Data Management and Quality Control, 8. Reporting of Results, 9. Pitfalls, 10. Exploratory Analyses, 11. Summary and Conclusions, References, Index
Stephanie Green, Jacqueline Benedetti
"This book provides a very clear and concise overview of the main
issues in the design, data management, and analysis of clinical
trials. Although the examples used are from oncology trials, the
principles apply to all clinical trials and so will be of use to a
wide audience. The book is well written and easy to read …
recommended reading to anyone involved in the design and running of
clinical trials, not just statisticians, although some familiarity
with statistical terminology would help. … a very useful and
accessible reference, which covers the essential statistical
elements of designing and running clinical trials all in one book,
which is extensively illustrated with real examples."
—ISCB News, 57, June 2014Praise for Previous Editions:"The
dedication of the authors to enhancing the quality of clinical
trials in oncology is evident from this book. … This book will be
useful to students, clinical research nurses and medical
statisticians involved in oncology trials. … I also recommend it to
libraries and clinical institutions."
—Clinical Trials, 2004
"With over 60 years combined experience, the authors are ideally
positioned to discuss the various statistical issues apparent in
clinical trials, identifying alternative solutions, providing
logical arguments for and against the various solutions. This book
is also recommended for statisticians actively involved in the
design, conduct, and analysis of clinical trial data (not only
cancer clinical trials)."
—Journal of Biopharmaceutical Statistics"A concise, easily
readable, and thorough summary…ALL medical oncology, radiation
oncology, surgical oncology, and clinical research nurse academic
training programs should provide this important text to trainees on
Day 1."
—Charles R. Thomas Jr., MD, University of Texas Health Science
Center at San Antonio, USA
"Succinct and focused…[This book] is clear, cogent, and practical.
It is structured so that statisticians can use specific sections as
starting point to develop shared understandings with investigators,
study coordinators, and data managers…It has been useful to me and
my clients, and I look forward to the second edition."
—Marlene Egger, University of Utah, USA
"This book provides a very clear and concise overview of the main
issues in the design, data management, and analysis of clinical
trials. Although the examples used are from oncology trials, the
principles apply to all clinical trials and so will be of use to a
wide audience. The book is well written and easy to read …
recommended reading to anyone involved in the design and running of
clinical trials, not just statisticians, although some familiarity
with statistical terminology would help. … a very useful and
accessible reference, which covers the essential statistical
elements of designing and running clinical trials all in one book,
which is extensively illustrated with real examples."
—ISCB News, 57, June 2014Praise for the Previous Editions:
"The dedication of the authors to enhancing the quality of clinical
trials in oncology is evident from this book. … This book will be
useful to students, clinical research nurses and medical
statisticians involved in oncology trials. … I also recommend it to
libraries and clinical institutions."
—Clinical Trials, 2004
"With over 60 years combined experience, the authors are ideally
positioned to discuss the various statistical issues apparent in
clinical trials, identifying alternative solutions, providing
logical arguments for and against the various solutions. This book
is also recommended for statisticians actively involved in the
design, conduct, and analysis of clinical trial data (not only
cancer clinical trials)."
—Journal of Biopharmaceutical Statistics"A concise, easily
readable, and thorough summary…ALL medical oncology, radiation
oncology, surgical oncology, and clinical research nurse academic
training programs should provide this important text to trainees on
Day 1."
—Charles R. Thomas Jr., MD, University of Texas Health Science
Center at San Antonio, USA
"Succinct and focused…[This book] is clear, cogent, and practical.
It is structured so that statisticians can use specific sections as
starting point to develop shared understandings with investigators,
study coordinators, and data managers…It has been useful to me and
my clients, and I look forward to the second edition."
—Marlene Egger, University of Utah, USA
![]() |
Ask a Question About this Product More... |
![]() |