Clinical Evaluation of Medical Devices: Principles and Case StudiesKaren M. Becker, John J. Whyte The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs. |
From inside the book
Results 1-5 of 87
Page 6
... procedures. Exposure to the product is not readily terminated or without irreversible consequences to patient. Placebo control groups (sham-surgery) are not possible. Medically appropriate alternative treatment regimens may not be ...
... procedures. Exposure to the product is not readily terminated or without irreversible consequences to patient. Placebo control groups (sham-surgery) are not possible. Medically appropriate alternative treatment regimens may not be ...
Page 11
... procedures for systematic evaluation of postmarket experience directed toward investigating product failures and successes and may include research (bench testing or clinical) to improve product performance and safety. In addition to ...
... procedures for systematic evaluation of postmarket experience directed toward investigating product failures and successes and may include research (bench testing or clinical) to improve product performance and safety. In addition to ...
Page 12
... procedures and duration Screening and assignment to treatment Assessments and follow-up Training procedures (if appropriate) Sample-size calculations Data analysis plan Risk analysis Case report forms Informed consent forms ...
... procedures and duration Screening and assignment to treatment Assessments and follow-up Training procedures (if appropriate) Sample-size calculations Data analysis plan Risk analysis Case report forms Informed consent forms ...
Page 14
... procedure or treatments. For surgical trials, it is especially critical to work with clinical investigators at all sites to develop a consensus to the greatest extent possible on surgical procedures to be used. Uniformity of procedures ...
... procedure or treatments. For surgical trials, it is especially critical to work with clinical investigators at all sites to develop a consensus to the greatest extent possible on surgical procedures to be used. Uniformity of procedures ...
Page 15
... procedure is not available. Historical controls should be used only if the quality of the data set is deemed to be reliable ... Procedures and Duration This section of the protocol Clinical Trial Development and Marketing Medical Devices 15.
... procedure is not available. Historical controls should be used only if the quality of the data set is deemed to be reliable ... Procedures and Duration This section of the protocol Clinical Trial Development and Marketing Medical Devices 15.
Contents
21 | |
Requirements for Medicare Coverage | 59 |
Postmarket Requirements for Significant Risk Devices 81 Suzan Onel | 99 |
Intellectual Property Protection for Medical Devices | 117 |
HIPAA Compliance in Clinical Research 141 Peter M Kazon and Sharon D Brooks | 153 |
Developing DrugDevice Combination Products | 161 |
Wall Streets Perspective on Medical Device | 187 |
Left Ventricular Assist Device | 199 |
A Randomized ShamProcedure | 217 |
Use of Multiple Imputation Models | 251 |
Case Studies on the Local Coverage Process 253 Mitchell I Burken | 269 |
Role of Device Retrieval and Analysis | 305 |
Other editions - View all
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2007 |
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2010 |
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2005 |
Common terms and phrases
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