Clinical Evaluation of Medical Devices: Principles and Case Studies

ISBN-13: 9781617370403 / Angielski / Miękka / 2010 / 271 str.

Karen Becker Witkin

Opis

The world is changing rapidly, and nowhere is this more apparent than in medicine. The standards are rapidly rising in the field of medical device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials conducted for medical device and drug development programs. More than 20 years after the enactment of the US Medical Device Amendments, we can see that they served as an impetus to raise clinical trial standards for devices. Whether the data to establish the safety and efficacy of a device come from one, two, or even more clinical trials is less important in evaluating the device than whether the data are medically and scientifically support ive of its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries."

Spis treści

Foreword, Bert Spilker. Part I. Fundamentals of Clinical Study Design and Evaluation. Clinical Trials in Development and Marketing of Medical Devices, Karen Becker Witkin. Observational Research: The Nonexperimental Approach, Rosanne B. McTyre and Linda M. Pottern. Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices, Selma A. Kunitz, Michele Gargano, and Rene Kozloff. Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics, Sharon A. Segal. Part II. Introduction to Case Studies, Karen Becker Witkin. Clinical Studies of Prosthetic Heart Valves Using Historical Controls, Gary L. Grunkemeier. Prospective Multicenter Clinical Trials in Orthopedics: Special Concerns and Challenges, John D. van Vleet. Long-Term Evaluation of Total Hip Arthroplasty, Frederick J. Dorey. Injectable Collagen and a Rare Adverse Event-True Association or Artifact?: Results of Postmarket Surveillance Research, Diane E. Mandell, Rosanne B. McTyre, Frank DeLustro, and Ross Erickson. In Vitro Diagnostics: Design of Clinical Studies to Validate Effectiveness, Wayne R. Patterson. A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Knee, Roberto Fiorentini, Frank C. Dorsey, Sharon A. Segal, and Roland Moskowitz. Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves, Frederick J. Schoen. Polyurethane Pacemaker Leads: The Contribution of Clinical Experience to the Elucidation of Failure Modes and Biodegradation Mechanisms, Ken Stokes. Glossary. Index.

Blurb

In Clinical Evaluation of Medical Devices Karen Becker Witkin and her distinguished colleagues summarize for the first time the key principles and approaches to be used in medical device clinical trials, and then demonstrate the implementation of these principles in a revealing series of detailed, real-world case studies. Building on the techniques used in clinical trials of pharmaceuticals, these highly experienced contributors show how to design and evaluate clinical trials of medical devices, as well as how best to collect data that is acceptable to the FDA. They also explain when, why, and how clinical research fits into the development and marketing of new product concepts and spell out international regulatory requirements for research and registration of medical devices. Nine detailed case studies illustrate the wide range of study designs that have been successfully applied to many different research problems and a variety of therapeutic or diagnostic products.

Clinical Evaluation of Medical Devices will not only play a key role in establishing clinical trials of medical devices as a rigorous science, but also provide today's only source of case-study-based practical information on how clinical study design principles are best tailored to the successful evaluation of novel medical devices.