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 66
Page 3
... defined in the federal Food, Drug, and Cosmetic (FD&C) Act, the term medical device: ...means an instrument ... definition of medical devices encompasses literally tens of thousands of different types of health care products, including ...
... defined in the federal Food, Drug, and Cosmetic (FD&C) Act, the term medical device: ...means an instrument ... definition of medical devices encompasses literally tens of thousands of different types of health care products, including ...
Page 12
... Definition of trial success (if hypothesis-testing study) Study procedures and duration Screening and assignment to treatment Assessments and follow-up Training procedures (if appropriate) Sample-size calculations Data analysis plan ...
... Definition of trial success (if hypothesis-testing study) Study procedures and duration Screening and assignment to treatment Assessments and follow-up Training procedures (if appropriate) Sample-size calculations Data analysis plan ...
Page 13
... definition of the patient population is significant because the approved PMA will generally have a label, which only supports use in the study population evaluated. 4.5. Treatment Regimen The nature of the intervention under study ...
... definition of the patient population is significant because the approved PMA will generally have a label, which only supports use in the study population evaluated. 4.5. Treatment Regimen The nature of the intervention under study ...
Page 14
... defined patient population. By definition, the control group comprises a set of patients or subjects who are not exposed to the intervention or device. There are two broad categories of control groups: concurrent controls and ...
... defined patient population. By definition, the control group comprises a set of patients or subjects who are not exposed to the intervention or device. There are two broad categories of control groups: concurrent controls and ...
Page 15
... Definition of Trial Success If the clinical trial is a hypothesis-testing study, it is powered to detect a clinically meaningful difference in treatment and control. This is usually expressed as the magnitude of some clinical outcome ...
... Definition of Trial Success If the clinical trial is a hypothesis-testing study, it is powered to detect a clinically meaningful difference in treatment and control. This is usually expressed as the magnitude of some clinical outcome ...
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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