Chin / Bairu Global Clinical Trials

Effective Implementation and Management
1. Auflage 2011
ISBN: 978-0-12-381538-5
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 522 Seiten

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA

Autoren/Hrsg.

Chin, Richard

Bairu, Menghis

Inhaltsverzeichnis

1;Front Cover;1
2;Dedication;3
3;Global Clinical Trials;4
4;Copyright;5
5;Contents;6
6;About the Editiors;14
7;Foreword;16
8;Contributors;18
9;Section 1 -Overview;22
9.1;Chapter 1 -Background;24
9.1.1;1.1 -Introduction;24
9.1.2;1.2 -Growth of Global Clinical Trials;25
9.1.3;1.3 -Drivers of Globalization;27
9.1.4;1.4 -Issues of Globalization;28
9.1.5;1.5 -Control and Inspections of Foreign Sites;29
9.1.6;1.6 -Ethnic and Genetic Differences;29
9.1.7;1.7 -Usability of International Clinical Data in Regulatory Filings;30
9.1.8;1.8 -World Health Organization Prequalification Process;33
9.1.9;References;38
9.2;Chapter 2 - Bioethical Considerations in Global Clinical Trials;40
9.2.1;2.1 -Introduction;40
9.2.2;2.2 -Ethical Standards and International Law;42
9.2.3;2.3 -Codes of Conduct;43
9.2.4;2.4 -Good Clinical Practice;49
9.2.5;References;50
9.3;Chapter 3 - United States Regulations;52
9.3.1;3.1 -Overview of the Food and Drug Administration in the USA;52
9.3.2;3.2 -The FDA’s Legal Authority;58
9.3.3;3.3 -Requirements for Approval;59
9.3.4;3.4 -Use of Foreign Clinical Data by the FDA;63
9.3.5;References;66
9.4;Chapter 4 Chapter 4 -European Union Regulations;68
9.4.1;4.1 -Overview of the European Union;68
9.4.2;4.2 -Overview of the European Medicines Agency;69
9.4.3;4.3 -EMA Committees;72
9.4.4;4.4 -Regulations and Guidance Related to Product Authorization;72
9.4.5;4.5 -EMA Good Clinical Practices;74
9.4.6;4.6 -Requirements for Marketing Authorization Applications;78
9.4.7;4.7 -Medical Device Clinical Trial Requirements;80
9.4.8;References;83
9.5;Chapter 5 - Japanese Regulations;84
9.5.1;5.1 -Introduction;85
9.5.2;5.2 -Documents Required for Application;85
9.5.3;5.3 -Review Process for New Drug Applications;92
9.5.4;5.4 -Required Surveys;93
9.5.5;5.5 -Contents Reviewed in the Drug Approval Application;94
9.5.6;5.6 -Differences Between J-GCP and ICH-GCP;95
9.5.7;5.7 -Notification of the Intent to Perform Clinical Trials;96
9.5.8;References;105
10;Section 2 -Bioethical Considerations in Global Clinical Trials;108
10.1;Chapter 6 - Indian Regulatory Framework;110
10.1.1;6.1 -Introduction;111
10.1.2;6.2 -Regulatory Hierarchy;113
10.1.3;6.3 -Central Drugs Standard Control Organization;114
10.1.4;6.4 -Norms and Regulations for the Conduct of Global Trials;116
10.1.5;6.5 -Obtaining Permission for Conducting a Clinical Trial;125
10.1.6;6.6 -Health Ministry’s Screening Committee Clearance;126
10.1.7;6.7 -Clinical Trials Registration;128
10.1.8;6.8 -Special Considerations;129
10.1.9;6.9 -New Initiatives;137
10.1.10;6.10 -Conclusion;138
10.1.11;Acknowledgments;138
10.1.12;References;138
10.2;Chapter 7 -Clinical Trials in India;140
10.2.1;7.1 -Introduction;141
10.2.2;7.2 -India: Background;141
10.2.3;7.3 -Demographics;142
10.2.4;7.4 -Disease Profile;143
10.2.5;7.5 -Healthcare System;145
10.2.6;7.6 -Indian Pharmaceutical Market;146
10.2.7;7.7 -India’s Changing Intellectual Property Rights Environment;147
10.2.8;7.8 -Regulatory Environment;148
10.2.9;7.9 -Ethics Committee Approval;157
10.2.10;7.10 -Good Clinical Practice In India;159
10.2.11;7.11 -FDA Audit and Inspection: Outcomes and Findings;161
10.2.12;7.12 -Language;161
10.2.13;7.13 -India’s Clinical Trial Sector;162
10.2.14;7.14 -Access to Patients;165
10.2.15;7.15 -Access to Investigators;167
10.2.16;7.16 -Access to Clinical Sites;168
10.2.17;7.17 -Working Effectively with Indian Clinical Trial Sites;169
10.2.18;7.18 -Pharmacovigilance;171
10.2.19;7.19 -Data Management Services;172
10.2.20;7.20 -Clinical Trial Supply Management in India;173
10.2.21;7.21 -Cost of Clinical Trial Services;173
10.2.22;7.22 -Clinical Trial Staff;174
10.2.23;7.23 -Conducting Trials in India;175
10.2.24;7.24 -Importance of India’s Clinical Trials Sector;176
10.2.25;References;177
10.3;Chapter 8 -Chinese Regulatory Framework;180
10.3.1;8.1 -Overview of Drug Administration in China;180
10.3.2;8.2 -Drug Registration;183
10.3.3;References;189
10.4;Chapter 9 -Clinical Trials in China;190
10.4.1;9.1 -Introduction;191
10.4.2;9.2 -Regulatory Climate;193
10.4.3;9.3 -Current Status and Statistics on Clinical Trials;197
10.4.4;9.4 -Overview of Investigators and Sites in China;198
10.4.5;9.5 -Contract Research Organizations;207
10.4.6;9.6 -Challenges and Opportunities;208
10.4.7;References;209
10.5;Chapter 10 -Clinical Trials in Taiwan;212
10.5.1;10.1 -Introduction;213
10.5.2;10.2 -Regulatory Climate;214
10.5.3;10.3 -Current Status and Statistics on Clinical Trials;217
10.5.4;10.4 -Overview of Investigators and Sites in Taiwan;218
10.5.5;10.5 -Contract Research Organizations;220
10.5.6;10.6 -Challenges and Opportunities;221
10.5.7;Acknowledgments;224
10.5.8;References;224
10.6;Chapter 11 -Clinical Trials in the Philippines;226
10.6.1;11.1 -Introduction;226
10.6.2;11.2 -Regulatory Climate;229
10.6.3;11.3 -Current Status and Statistics on Clinical Trials;233
10.6.4;11.4 -Overview of Investigators and Sites in the Philippines;234
10.6.5;11.5 -Challenges and Opportunities;236
10.6.6;References;237
10.7;Chapter 12 -Clinical Trials in the Middle East and North Africa;238
10.7.1;12.1 -Introduction;238
10.7.2;12.2 -Clinical Trial Status;241
10.7.3;12.3 -Infrastructure and System of Healthcare;244
10.7.4;12.4 -Patient Profile;264
10.7.5;12.5 -Challenges and Opportunities;265
10.7.6;References;265
10.8;CHAPTER 13 -Clinical Trials in South Africa;266
10.8.1;13.1 -Introduction;266
10.8.2;13.2 -Geography;267
10.8.3;13.3 -Healthcare System and Infrastructure;268
10.8.4;13.4 -Disease Profile;270
10.8.5;13.5 -History of Clinical Trials in South Africa;271
10.8.6;13.6 -Regulation of Clinical Trials;272
10.8.7;13.7 -Ethics Committees;275
10.8.8;13.8 -Good Clinical Practice;277
10.8.9;13.9 -Clinical Trial Status;278
10.8.10;13.10 -Participant Profile;279
10.8.11;13.11 -Inspections;281
10.8.12;13.12 -Pharmacovigilance;282
10.8.13;13.13 -Staffing of Clinical Trials;284
10.8.14;13.14 -Logistics;285
10.8.15;13.15 -Clinical Trial Industry Associations;287
10.8.16;13.16 -Challenges and Opportunities;287
10.8.17;References;289
10.9;CHAPTER 14 -Clinical Trials in Latin America;292
10.9.1;14.1 -Introduction;293
10.9.2;14.2 -Regulatory Climate;299
10.9.3;14.3 -Current Status and Statistics on Clinical Trials;317
10.9.4;14.4 -Overview of Investigators and Sites in Latin America;318
10.9.5;14.5 -Contract Research Organizations;322
10.9.6;14.6 -Challenges and Opportunities;327
10.9.7;References;329
10.10;Chapter 15 -Clinical Trials in Central and Eastern Europe;330
10.10.1;15.1 -Czech Republic;333
10.10.2;15.2 -Hungary;340
10.10.3;15.3 -Latvia;343
10.10.4;15.4 -Estonia;348
10.10.5;15.5 -Poland;354
10.10.6;15.6 -Romania;360
10.10.7;15.7 -Ukraine;366
10.10.8;15.8 -Russia;372
11;Section 3 -Clinical Study Logistics;378
11.1;Chapter 16 -Design of Clinical Trials for Emerging Countries;380
11.1.1;16.1 -Introduction;380
11.1.2;16.2 -Opportunities;381
11.1.3;16.3 -Challenges;384
11.1.4;16.4 -Recommendations;388
11.1.5;16.5 -Conclusion;401
11.1.6;References;401
11.2;Chapter 17 -Study Management;402
11.2.1;17.1 -Introduction;403
11.2.2;17.2 -Planning and Project Management;409
11.2.3;17.3 -Selection, Qualification, and Management of Contract Research Organizations;410
11.2.4;17.4 -Central Laboratory Considerations;415
11.2.5;Acknowledgment;421
11.2.6;References;421
11.3;Chapter 18 -Study Documents and Logistics;422
11.3.1;18.1 -Introduction;423
11.3.2;18.2 -Writing the Study Protocol;423
11.3.3;18.3 -Writing the Investigator’s Brochure;425
11.3.4;18.4 -Informed Consent and the Informed Consent Form;428
11.3.5;18.5 -Chemistry, Manufacturing, and Controls;431
11.3.6;18.6 -Drug Supply and Labeling;433
11.3.7;18.7 -Interactive Voice Response Technology;435
11.3.8;18.8 -Investigators’ Meeting;438
11.3.9;18.9 -Electrical Generators and Power Issues;441
11.3.10;18.10 -Translations;442
11.3.11;Acknowledgment;443
11.3.12;References;443
11.4;Chapter 19 -Clinical Study Conduct and Monitoring;444
11.4.1;19.1 -Regulations and Harmonization;445
11.4.2;19.2 -Preclinical Study, and Chemistry, Manufacturing, and Control;446
11.4.3;19.3 -Phases of Clinical Development;447
11.4.4;19.4 -Clinical Study Conduct;450
11.4.5;19.5 -Clinical Study Team;451
11.4.6;19.6 -Clinical Study Protocol;452
11.4.7;19.7 -Case Report Forms;455
11.4.8;19.8 -Data and Safety Monitoring Board;456
11.4.9;19.9 -Investigational New Drug Application and the Food and Drug Administration;456
11.4.10;19.10 -Protecting the Research Subjects;463
11.4.11;19.11 -Study Start-Up;469
11.4.12;19.12 -Clinical Study Binder;476
11.4.13;19.13 -Subject/Patient Recruitment;479
11.4.14;19.14 -Site Monitoring Visits;481
11.4.15;19.15 -End of Study;484
11.4.16;19.16 -Audits and Inspections;487
11.4.17;References;489
11.5;Chapter 20 -Data Collection, Data Management, and Electronic Data Capture;492
11.5.1;20.1 -Introduction;492
11.5.2;20.2 -The Electronic Data Capture Evaluation Team;494
11.5.3;20.3 -Electronic Data Capture Vendor Selection;496
11.5.4;20.4 -Narrowing the Field: Strategies for Second Round Selection;499
11.5.5;20.5 -Final Review;499
12;Index;508
13;Colorplates;524