Clinical Evaluation of Medical Devices

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.

Klappentext

Building on the techniques used in clinical trials of pharmaceuticals, this book summarizes for the first time the key principles and approaches to be used in medical device clinical trials, and then demonstrates implementation of these principles in a revealing series of detailed, real-world case studies. The highly experienced contributors show how to design and evaluated clinical trials of medical defvices, as well as collect data that is acceptable to the FDA. 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 provides today's only source of case-study-based practical information on how clinical study design principles are best tailored to the successful evaluation of medical devices. This book serves as a technical resource for scientific and regulatory professionals working in the field of new medical device development and commercialization. Chapters cover the basic principles of clinical study design and analysis, (including protocol requirements, selecting suitable endpoints, selecting a control group, sample size calculations, monitoring, data analysis, and presentation); and those describing research approaches on different classes of such devices as implanted devices and in vitro diagnostics.

Inhalt
I. Fundamentals of Clinical Study Design and Evaluation.- 1 Clinical Trials in Development and Marketing of Medical Devices.- 2 Observational Research: The Nonexperimental Approach.- 3 Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices.- 4 Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics.- II. Introduction to Case Studies.- 5 Clinical Studies of Prosthetic Heart Valves Using Historical Controls.- 6 Prospective Multicenter Clinical Trials in Orthopedics: Special Concerns and Challenges.- 7 Long-Term Evaluation of Total Hip Arthroplasty.- 8 Injectable Collagen and a Rare Adverse EventTrue Association or Artifact?: Results of Postmarket Surveillance Research.- 9 In Vitro Diagnostics: Design of Clinical Studies to Validate Effectiveness.- 10 A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Knee.- 11 Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves.- 12 Polyurethane Pacemaker Leads: The Contribution of Clinical Experience to the Elucidation of Failure Modes and Biodegradation Mechanisms.