New Medical Devices Monograph Launched By Institute Of Clinical Research

The Institute of Clinical Research (ICR) has announced the launch of a new monograph: The Challenges of Conducting Medical Device Studies (ISBN:09549345-55-5).

Written by Keith Summerhayes and Selvarajah Shankar, in conjunction with the ICR's Medical Device Subcommittee, this monograph has been written to be of value to staff members of the medical device clinical affairs team at all levels. Whilst the book is primarily aimed at UK/European study conduct, the vast majority of the issues are common with the USA, Australia, Canada and Japan and, where appropriate, major differences have been highlighted and discussed.

Chair of the ICR Medical Device Special Interest Group, Janette Benaddi explains; "The Medical Device monograph was developed by members of the medical devices special interest group, many of whom are considered experts in the field of medical device research. The monograph provides an excellent practical guide to anyone undertaking medical device clinical studies in addition to providing concise and easy to read regulatory guidance.

"There are vast bodies of text hidden away in formal documents, guidelines, standards, Directives and Web sites on the conduct of clinical studies. Some even contain information about medical device clinical studies but it is not always obvious what the best sources of information are.

"The overall purpose of this work is to remove some of the opacity that surrounds medical devices clinical research and shed some light on the regulations that govern them and the practical issues that need attention.

"The main aim is to give a basic understanding of the generic issues involved in the conduct of medical device studies, but boxed items throughout the publication give a deeper understanding and also an insight into where to find more information on specific topics."

SOURCE: ICR