Design, Execution, and Management of Medical Device Clinical Trials (PDF)

An essential introduction to conducting the various stages of
medical device clinical trials

Clinical research continues to be one of the most vital
components of pharmaceutical, biostatistical, and medical studies.
Design, Execution, and Management of Medical Device Clinical Trials
provides a uniform methodology for conducting and managing clinical
trials. Written in a style that is accessible to readers from
diverse educational and professional backgrounds, this book
provides an in-depth and broad overview for successfully performing
clinical tasks and activities.

Throughout the book, practical examples compiled from both the
author's and other researchers' previous clinical trial experiences
are discussed in a sequential manner as they occur in the study,
starting from the development of the clinical protocol and the
selection of clinical sites and ending with the completion of the
final clinical study report. Next, readers are guided through the
development of important clinical documents, including informed
consent forms, case report forms, and study logs. A careful review
of the Food and Drug Administration (FDA) and International
Conference on Harmonisation (ICH) regulations applicable to medical
devices is also featured. Additional coverage includes:

* Qualification and selection of investigators

* Study monitoring visits

* Definitions and reporting procedures for adverse events

* The use of biostatistical methodology in clinical research,
including the use of biostatistics for sample size determination
and study endpoints

* The roles and responsibilities of all members of a clinical
research team

The book concludes with an insightful discussion of special
ethical conduct for human research and challenging issues to
consider during the design of clinical studies. A glossary lists
important clinical and statistical terms used in clinical research,
and an extensive reference section provides additional resources
for the most up-to-date literature on the topic.

Design, Execution, and Management of Medical Device Clinical
Trials is an excellent book for clinical research or epidemiology
courses at the upper-undergraduate and graduate levels. It is also
an indispensable reference for clinical research associates,
clinical managers, clinical scientists, biostatisticians,
pharmacologists, and any professional working in the field of
clinical research who would like to better understand clinical
research practices.