9780853697909

This text is a one-stop source for guidance and checking the rules for proper conduct of clinical trials, functioning as a textbook for students in clinical development and as a handbook for existing pharmaceutical company employees.

Michael J. McGraw is Senior Manager, Regulatory Affairs, Teva Neuroscience, Inc. and Adjunct Associate Professor, Temple University, USA. Adam N. George is Medical Information Manager, Cephalon, Inc. and Adjunct Associate professor, Temple University, USA.

Preface	p. ix
About the editors	p. x
Contributors	p. xii
Abbreviations	p. xiv
Introduction to Good Clinical Practice	p. 1
Regulatory requirements	p. 15
Introduction	p. 15
International Conference on Harmonisation requirements	p. 15
The United States (US) regulatory framework	p. 17
The European Union regulatory framework	p. 27
Summary	p. 37
Informed consent	p. 41
Background	p. 42
Regulations and guidelines	p. 44
Introduction to form and process	p. 44
Liability, understanding, therapeutic misconception	p. 51
Developing a 'gold standard'	p. 54
Leadership	p. 57
Additional topics	p. 57
Summary	p. 60
Investigator responsibilities	p. 63
Qualifications	p. 64
Assessment of the research	p. 65
Communication with the Institutional Review Board or Independent Ethics Committee	p. 67
Communication with sponsor	p. 68
Protecting safety, rights, and welfare of subjects	p. 68
Investigational product	p. 71
Safety reporting	p. 73
Assessment of causality	p. 73
Documentation and record retention	p. 74
Financial disclosure	p. 75
Inspections by health authorities	p. 75
Summary	p. 75
Sponsor responsibilities	p. 77
Quality	p. 77
Medical expertise	p. 78
Study design	p. 79
Data management	p. 80
Record keeping	p. 81
Safety reporting	p. 83
Investigator selection	p. 86
Investigational product	p. 86
Registration of clinical trials	p. 88
Reporting of clinical trial results	p. 88
Summary	p. 89
Clinical trial design	p. 91
Introduction	p. 91
What is clinical research?	p. 91
Historical perspective on clinical research	p. 92
Why is clinical research needed?	p. 92
The phases of drug development	p. 93
Where does clinical research begin?	p. 95
Critical concepts in clinical research	p. 95
Approaches to the design of clinical research studies	p. 95
Bias in clinical research	p. 98
Type I error, Type II error, and sample size	p. 100
Equivalency/non-inferiority versus superiority in clinical trials	p. 102
Clinical equipoise in controlled clinical trials	p. 104
Comparison of placebo versus the best-available control group in controlled clinical studies	p. 105
Challenges in conducting clinical research	p. 105
The interpretation and integration of clinical research into clinical practice	p. 106
Site monitoring	p. 109
Selection and qualifications of the monitor	p. 109
The evaluation visit	p. 110
The initiation visit	p. 112
The monitoring visit	p. 114
The close-out visit	p. 117
Summary	p. 119
Institutional Review Boards and Independent Ethics Committees	p. 121
Composition, procedures, and function	p. 122
Protection of human subjects	p. 125
Review of the protocol, Investigator's Brochure, and informed consent	p. 128
Qualifications of the investigator and investigative team	p. 138
Risk-benefit analysis	p. 139
Continuing review	p. 144
Final thoughts	p. 145
Pharmacovigilance	p. 149
Introduction	p. 149
Adverse events	p. 150
Reporting guidelines and timeline	p. 153
Signal detection	p. 159
Databases	p. 161
Conclusion	p. 163
Clinical trial registration and reporting	p. 167
Introduction and history	p. 167
Clinical trial registration	p. 170
Clinical trial results databases	p. 175
Legislation and regulatory requirements	p. 177
Clinical trial disclosure implications for future therapeutic development	p. 178
Summary	p. 180
Quality assurance	p. 183
Introduction	p. 183
Defining quality	p. 184
Auditing: purpose of auditing	p. 185
The audit plan	p. 186
Conduct of the audit	p. 188
Types of audit	p. 188
Summary	p. 200
Future implications of Good Clinical Practice	p. 203
Globalization of clinical research	p. 203
Genomics	p. 205
Gene transfer	p. 207
Stem cell research	p. 208
Nanotechnology	p. 210
Conclusion	p. 212
The Nuremberg Code	p. 215
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects	p. 217
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research	p. 223
Glossary	p. 235
Index	p. 245
Table of Contents provided by Ingram. All Rights Reserved.

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Principles of Good Clinical Practice

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