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
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Page 3
... observed in medical device studies are influenced not only by the product under evaluation and the patient, but also by the skill and discretion of the user, who is typically a health care professional but may be the patient. The impact ...
... observed in medical device studies are influenced not only by the product under evaluation and the patient, but also by the skill and discretion of the user, who is typically a health care professional but may be the patient. The impact ...
Page 13
... observed. For a pivotal clinical trial intended to support FDA approval, the definition of the patient population is significant because the approved PMA will generally have a label, which only supports use in the study population ...
... observed. For a pivotal clinical trial intended to support FDA approval, the definition of the patient population is significant because the approved PMA will generally have a label, which only supports use in the study population ...
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... observed contemporaneously with the experimental group. The most common nonconcurrent control is the historical control group, comprising a cohort previously observed, treated, studied, or reported on. Historical control groups must be ...
... observed contemporaneously with the experimental group. The most common nonconcurrent control is the historical control group, comprising a cohort previously observed, treated, studied, or reported on. Historical control groups must be ...
Page 15
... observed adverse events, regardless of whether they are deemed to be device-related at the time. 4.8. Definition of Trial Success If the clinical trial is a hypothesis-testing study, it is powered to detect a clinically meaningful ...
... observed adverse events, regardless of whether they are deemed to be device-related at the time. 4.8. Definition of Trial Success If the clinical trial is a hypothesis-testing study, it is powered to detect a clinically meaningful ...
Page 38
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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
addition analysis application appropriate approval assessment associated authorization Bayesian benefit cardiac Center changes claims clinical trial codes component conducted considered costs coverage covered criteria decision defined determine disease distribution drug effect entity established evaluation example failure filed Food function heart hospital human identify implanted important improvement imputation individual initial invention investigational issues lead limited manufacturer measures mechanism medical devices Medicare meet ment methods missing multiple necessary observed obtain outcome patients payment performance potential present primary prior procedures protection rail randomized reasonable received regulations regulatory reimbursement request risk Rule safety significant specific sponsor standard stent studies subjects testing therapy tion tray treatment typically values valve