Clinical Evaluation of Medical Devices

1. Front Matter

   Pages i-xi

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2. Fundamentals of Clinical Study Design and Evaluation

   1. Front Matter

      Pages 1-1

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   2. Clinical Trials in Development and Marketing of Medical Devices

      • Karen Becker Witkin

      Pages 3-21

   3. Observational Research

      • Rosanne B. McTyre, Linda M. Pottern

      Pages 23-40

   4. Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices

      • Selma A. Kunitz, Michele Gargano, Rene Kozloff

      Pages 41-58

   5. Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics

      • Sharon A. Segal

      Pages 59-78

3. Introduction to Case Studies

   1. Front Matter

      Pages 79-81

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   2. Clinical Studies of Prosthetic Heart Valves Using Historical Controls

      • Gary L. Grunkemeier

      Pages 83-102

   3. Prospective Multicenter Clinical Trials in Orthopedics

      • John D. Van Vleet

      Pages 103-132

   4. Long-Term Evaluation of Total Hip Arthroplasty

      • Frederick J. Dorey

      Pages 133-149

   5. Injectable Collagen and a Rare Adverse Event—True Association or Artifact?

      • Diane E. Mandell, Rosanne B. McTyre, Frank DeLustro, Ross Erickson

      Pages 151-164

   6. In Vitro Diagnostics

      • Wayne R. Patterson

      Pages 165-189

   7. A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Knee

      • Roberto Fiorentini, Frank C. Dorsey, Sharon A. Segal, Roland Moskowitz

      Pages 191-207

   8. Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves

      • Frederick J. Schoen

      Pages 209-231

   9. Polyurethane Pacemaker Leads

      • Ken Stokes

      Pages 233-255

4. Back Matter

   Pages 257-271

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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.

• biodegradation
• control
• data analysis
• design
• development
• diagnostics
• hip arthroplasty
• information
• marketing
• mechanism
• mechanisms
• medical devices
• medicine
• research
• safety

• The Weinberg Group, Inc., USA

  Karen Becker Witkin

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