| dc.description.abstract | The clinical trial is “the most definitive tool for evaluation of the applicability of
clinical research.” It represents “a key research activity with the potential to
improve the quality of health care and control costs through careful comparison
of alternative treatments” [1]. It has been called on many occasions, “the gold
standard” against which all other clinical research is measured.
Although many clinical trials are of high quality, a careful reader of the medical
literature will notice that a large number have deficiencies in design, conduct,
analysis, presentation, and/or interpretation of results. Improvements have occurred
over the past few decades, but too many trials are still conducted without adequate
attention to the fundamental principles. Certainly, numerous studies could have
been improved if the authors had had a better understanding of the fundamentals.
Since the publication of the first edition of this book in 1981, a large number of
other texts on clinical trials have appeared, most of which are indicated here [2–21].
Several of them, however, discuss only specific issues involved in clinical trials.
Additionally, many are no longer current. The purpose of this fifth edition is to
update areas in which major progress has been made since the publication of the
fourth edition. We have revised most chapters considerably. Because it was becoming
unwieldy, we divided the chapter on monitoring response variables into two
chapters, one on monitoring committees and the other on monitoring approaches.
We also added a chapter on regulatory issues.
Importantly, two new authors are now involved. This brings fresh perspectives
to a book originally published over three decades ago.
In this book, we hope to assist investigators in improving the quality of their
clinical trials by discussing fundamental concepts with examples from our experience
and the literature. The book is intended both for investigators with some
clinical trial experience and for those who plan to conduct a trial for the first time.
It is also intended to be used in the teaching of clinical trial methodology and to assist
members of the scientific and medical community who wish to evaluate and interpret
published reports of trials. Although not a technically oriented book, it may be used as a reference for graduate courses in clinical trials. Those readers who wish to
consult more technical books and articles are provided with the relevant literature. | en_US |
