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Design, Execution, and Management of Medical Device Clinical Trials

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"Design, Execution, and Management of Medical Device Clinical Trials" Feature

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.

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Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents

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The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time.

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An Introduction to Medical Plastics

Catheter Forming Equipment and Operations

Basics of Catheter Construction

Basics of Medical Needles

Rapid Prototyping for Medical Devices

Reverse Engineering for Medical Devices

Using Medical Illustration in Product Development

Introduction to Pre-Clinical Studies

Introduction to Regulatory Affairs

Assessing Biocompatibility

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This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.

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Product Description : The Medical Device R&D Handbook

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