This is the fifth edition of a very successful textbook on clinical
trials methodology, written by recognized leaders who have long and
extensive experience in all areas of clinical trials. The three authors
of the first four editions have been joined by two others who add great
expertise. A chapter on regulatory issues has been included and the
chapter on data monitoring has been split into two and expanded. Many
contemporary clinical trial examples have been added. There is much new
material on adverse events, adherence, issues in analysis, electronic
data, data sharing and international trials.
This book is intended for the clinical researcher who is interested in
designing a clinical trial and developing a protocol. It is also of
value to researchers and practitioners who must critically evaluate the
literature of published clinical trials and assess the merits of each
trial and the implications for the care and treatment of patients. The
authors use numerous examples of published clinical trials to illustrate
the fundamentals.
The text is organized sequentially from defining the question to trial
closeout. One chapter is devoted to each of the critical areas to aid
the clinical trial researcher. These areas include pre-specifying the
scientific questions to be tested and appropriate outcome measures,
determining the organizational structure, estimating an adequate sample
size, specifying the randomization procedure, implementing the
intervention and visit schedules for participant evaluation,
establishing an interim data and safety monitoring plan, detailing the
final analysis plan and reporting the trial results according to the
pre-specified objectives.
Although a basic introductory statistics course is helpful in maximizing
the benefit of this book, a researcher or practitioner with limited
statistical background would still find most if not all the chapters
understandable and helpful. While the technical material has been kept
to a minimum, the statistician may still find the principles and
fundamentals presented in this text useful.
