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Design__Execution__and_Management_of_Medical_Device_Clinical_Trials.pdf
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Copyright . 2009 by John Wiley & Sons, Inc. All rights reserved.
Published by John Wiley & Sons, Inc., Hoboken, New Jersey.
Published simultaneously in Canada.
List of Abbreviations xi
Preface xv
Acknowledgments xxi
1 An Overview of Clinical Study Tasks and Activities 1
Key Clinical Study Tasks and Activities, 2
Discussion of Key Tasks and Activities, 3
Management of Key Clinical Tasks and Activities, 9
Example of the Spread Sheet for Managing Clinical
Study Activities, 10
The Clinical Research Team, 10
2 Development of Clinical Protocols, Case Report Forms,
Clinical Standard Operating Procedures, Informed
Consent Form, Study Regulatory Binder, Study Research
Agreement, and Other Clinical Materials 15
Clinical Protocol, 17
Case Report Forms (CRFs), 28
Example of the Case Report Form Template, 32
Informed Consent Form (ICF), 35
Instructions for Use of Device, 38
Study Regulatory Binder, 39
viii CONTENTS
Study Research Agreement, 40
Research Agreement Template, 43
Research Contract Challenges, 50
Clinical Forms and Certifi cates, 51
Clinical Standard Operating Procedures (SOPs), 54
3 Qualifi cation/Selection of Study Investigators and Study
Monitoring Visits 63
Qualifi cation and Selection of Investigators, 64
Monitoring Visits, 67
Monitoring Reports, 73
Interim Monitoring Visit Report Template, 75
4 Adverse Events Defi nitions and Reporting Procedures 81
Adverse Event Defi nitions, 83
Policies, Regulations, and Guidelines Regarding
Adverse Event Reporting, 84
Adverse Event Reporting Pathway, 84
Terms for Causality Assessment, 85
GAPS/Challenges in Adverse Event Reporting, 86
Adverse Event Reporting Time Periods
(21 CFR 803), 88
Differences between the United States and
Europe in Reporting Adverse Events, 88
Serious Adverse Event Narratives, 89
Classifi cation of Adverse Events, 90
Special Requirement for Reporting Certain
Adverse Events, 92
Case Example, 92
Mandatory Device Reporting for FDA-Approved
Devices, 92
5 Statistical Analysis Plan (SAP) and Biostatistics
in Clinical Research 93
Statistical Analysis Plan (SAP), 94
Selection of Study Endpoints, 97
Biostatistics in Clinical Research, 101
6 Final Clinical Study Report 113
Final Clinical Report’s Outline, 114
CONTENTS ix
Discussion of Sections in the Final Clinical Report, 116
7 Medical Device Regulations, Combination Product,
Study Committees, and FDA-Sponsor Meetings 127
Medical Device Regulations, 129
Combination Products, 164
Study Committees, 168
FDA-Sponsor Meetings, 170
Registration of Clinical Trials, 174
Implementation of the HIPAA Privacy Rule in Clinical
Research, 175
Institutional Review Boards (IRB), 180
FDA’s Oversight of Clinical Trials (Bioresearch
Monitoring), 191
Code of Federal Regulations of Medical Devices, 194
8 Design Issues in Medical Devices Studies 195
Design of the Clinical Trial, 196
Assumptions and Parameters of Clinical Trial
Design, 196
Clinical Trials’ Design Issues and Data Analysis
Issues, 202
Use of Historic Controls as the Control Group in
IDE Studies, 206
Summary of Recommendations When Using Historic
Controls, 218
9 Investigator-Initiated Clinical Research 221
Defi nition and Examples of Investigator-Initiated
Clinical Research, 222
Development, Conduct, and Management of
Investigator-Initiated Clinical Research, 224
Regulation of Investigator-Initiated
Clinical Research, 225
Required Infrastructure for Investigator-Initiated
Clinical Research, 226
Clinical Research Sponsored by NIH, 227
10 Ethical Conduct for Human Research 229
The Nuremberg Code (1947), 230
x CONTENTS
World Medical Association—Declaration
of Helsinki (1964–Present), 231
National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research (1974), 231
The Belmont Report (1978), 232
Special Ethical Concerns in Clinical Research on
Use of Placebo, 232
Glossary of Clinical Trial and Statistical Terms 235
References 249
Index 255
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