This book is intended to begin to fill this gap as a resource containing
information and reference material to help identify and understand the legal
issues, many of which are quite complex, that are associated with clinical
trials. This book is limited to American law, and it is beyond its scope to
discuss the legal aspects of international clinical trials, which is a topic
deserving of a book unto itself.3
On many occasions the author of this book has needed to consult a comprehensive
review of clinical trial law but could find only one book that came
close—Clinical Research Law and Compliance Handbook.4 It provides an
excellent and practical overview of regulatory and compliance requirements
in structuring a clinical trial, but does not deal with clinical issues raised
during the conduct of such trials to the extent this book does. The current
book, on the other hand, provides an overview of relevant regulatory schemes
and emphasizes and integrates into the reading cases involving the clinical
aspects of trials. As such, the work will be a resource/ research aid handbook
designed more for clinical investigators, their institution administrators, and
counsel.