Global Clinical Trials
Effective Implementation and Management
- 1st Edition - August 19, 2016
- Latest edition
- Editors: Richard Chin, Menghis Bairu
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 1 0 3 5 5 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 3 8 1 5 3 8 - 5
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 th… Read more
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
Physicians, researchers, clinical coordinators, biostatisticians, and data managers employed at academic medical centers, pharmaceutical companies, biotechnology companies, medical device companies, contract research organizations, and product development partnerships (non-profit pharmaceutical companies) who are interested in planning and executing clinical trials in developing countries
About the Editors
Foreword
Contributors
Chapter 1. Background
1.1. Introduction
1.2. Growth of Global Clinical Trials
1.3. Drivers of Globalization
1.4. Issues of Globalization
1.5. Control and Inspections of Foreign Sites
1.6. Ethnic and Genetic Differences
1.7. Usability of International Clinical Data in Regulatory Filings
1.8. World Health Organization Prequalification Process
Chapter 2. Bioethical Considerations in Global Clinical Trials
2.1. Introduction
2.2. Ethical Standards and International Law
2.3. Codes of Conduct
2.4. Good Clinical Practice
Chapter 3. United States Regulations
3.1. Overview of the Food and Drug Administration in the USA
3.2. The FDA’s Legal Authority
3.3. Requirements for Approval
3.4. Use of Foreign Clinical Data by the FDA
Chapter 4. European Union Regulations
4.1. Overview of the European Union
4.2. Overview of the European Medicines Agency
4.3. EMA Committees
4.4. Regulations and Guidance Related to Product Authorization
4.5. EMA Good Clinical Practices
4.6. Requirements for Marketing Authorization Applications
4.7. Medical Device Clinical Trial Requirements
Chapter 5. Japanese Regulations
5.1. Introduction
5.2. Documents Required for Application
5.3. Review Process for New Drug Applications
5.4. Required Surveys
5.5. Contents Reviewed in the Drug Approval Application
5.6. Differences Between J-GCP and ICH-GCP
5.7. Notification of the Intent to Perform Clinical Trials
Chapter 6. Indian Regulatory Framework
6.1. Introduction
6.2. Regulatory Hierarchy
6.3. Central Drugs Standard Control Organization
6.4. Norms and Regulations for the Conduct of Global Trials
6.5. Obtaining Permission for Conducting a Clinical Trial
6.6. Health Ministry’s Screening Committee Clearance
6.7. Clinical Trials Registration
6.8. Special Considerations
6.9. New Initiatives
6.10. Conclusion
Chapter 7. Clinical Trials in India
7.1. Introduction
7.2. India: Background
7.3. Demographics
7.4. Disease Profile
7.5. Healthcare System
7.6. Indian Pharmaceutical Market
7.7. India’s Changing Intellectual Property Rights Environment
7.8. Regulatory Environment
7.9. Ethics Committee Approval
7.10. Good Clinical Practice In India
7.11. FDA Audit and Inspection: Outcomes and Findings
7.12. Language
7.13. India’s Clinical Trial Sector
7.14. Access to Patients
7.15. Access to Investigators
7.16. Access to Clinical Sites
7.17. Working Effectively with Indian Clinical Trial Sites
7.18. Pharmacovigilance
7.19. Data Management Services
7.20. Clinical Trial Supply Management in India
7.21. Cost of Clinical Trial Services
7.22. Clinical Trial Staff
7.23. Conducting Trials in India
7.24. Importance of India’s Clinical Trials Sector
Chapter 8. Chinese Regulatory Framework
8.1. Overview of Drug Administration in China
8.2. Drug Registration
Chapter 9. Clinical Trials in China
9.1. Introduction
9.2. Regulatory Climate
9.3. Current Status and Statistics on Clinical Trials
9.4. Overview of Investigators and Sites in China
9.5. Contract Research Organizations
9.6. Challenges and Opportunities
Chapter 10. Clinical Trials in Taiwan
10.1. Introduction
10.2. Regulatory Climate
10.3. Current Status and Statistics on Clinical Trials
10.4. Overview of Investigators and Sites in Taiwan
10.5. Contract Research Organizations
10.6. Challenges and Opportunities
Chapter 11. Clinical Trials in the Philippines
11.1. Introduction
11.2. Regulatory Climate
11.3. Current Status and Statistics on Clinical Trials
11.4. Overview of Investigators and Sites in the Philippines
11.5. Challenges and Opportunities
Chapter 12. Clinical Trials in the Middle East and North Africa
12.1. Introduction
12.2. Clinical Trial Status
12.3. Infrastructure and System of Healthcare
12.4. Patient Profile
12.5. Challenges and Opportunities
Chapter 13. Clinical Trials in South Africa
13.1. Introduction
13.2. Geography
13.3. Healthcare System and Infrastructure
13.4. Disease Profile
13.5. History of Clinical Trials in South Africa
13.6. Regulation of Clinical Trials
13.7. Ethics Committees
13.8. Good Clinical Practice
13.9. Clinical Trial Status
13.10. Participant Profile
13.11. Inspections
13.12. Pharmacovigilance
13.13. Staffing of Clinical Trials
13.14. Logistics
13.15. Clinical Trial Industry Associations
13.16. Challenges and Opportunities
Chapter 14. Clinical Trials in Latin America
14.1. Introduction
14.2. Regulatory Climate
14.3. Current Status and Statistics on Clinical Trials
14.4. Overview of Investigators and Sites in Latin America
14.5. Contract Research Organizations
14.6. Challenges and Opportunities
Chapter 15. Clinical Trials in Central and Eastern Europe
15.1. Czech Republic
15.2. Hungary
15.3. Latvia
15.4. Estonia
15.5. Poland
15.6. Romania
15.7. Ukraine
15.8. Russia
Chapter 16. Design of Clinical Trials for Emerging Countries
16.1. Introduction
16.2. Opportunities
16.3. Challenges
16.4. Recommendations
16.5. Conclusion
Chapter 17. Study Management
17.1. Introduction
17.2. Planning and Project Management
17.3. Selection, Qualification, and Management of Contract Research Organizations
17.4. Central Laboratory Considerations
Chapter 18. Study Documents and Logistics
18.1. Introduction
18.2. Writing the Study Protocol
18.3. Writing the Investigator’s Brochure
18.4. Informed Consent and the Informed Consent Form
18.5. Chemistry, Manufacturing, and Controls
18.6. Drug Supply and Labeling
18.7. Interactive Voice Response Technology
18.8. Investigators’ Meeting
18.9. Electrical Generators and Power Issues
18.10. Translations
Chapter 19. Clinical Study Conduct and Monitoring
19.1. Regulations and Harmonization
19.2. Preclinical Study, and Chemistry, Manufacturing, and Control
19.3. Phases of Clinical Development
19.4. Clinical Study Conduct
19.5. Clinical Study Team
19.6. Clinical Study Protocol
19.7. Case Report Forms
19.8. Data and Safety Monitoring Board
19.9. Investigational New Drug Application and the Food and Drug Administration
19.10. Protecting the Research Subjects
19.11. Study Start-Up
19.12. Clinical Study Binder
19.13. Subject/Patient Recruitment
19.14. Site Monitoring Visits
19.15. End of Study
19.16. Audits and Inspections
Chapter 20. Data Collection, Data Management, and Electronic Data Capture
20.1. Introduction
20.2. The Electronic Data Capture Evaluation Team
20.3. Electronic Data Capture Vendor Selection
20.4. Narrowing the Field: Strategies for Second Round Selection
20.5. Final Review
Colorplates
Index
- Edition: 1
- Latest edition
- Published: August 19, 2016
- Language: English
RC
Richard Chin
Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar.
Affiliations and expertise
CEO, Oxigene
San Francisco, CA, USAMB
Menghis Bairu
Menghis Bairu, M.D.—physician, editor, author, philanthropist and healthcare business executive—has more than two decades of international experience in the biotechnology, pharmaceutical, global health and non-profit arenas. Dr. Bairu serves as Executive Vice President, Chief Medical Officer and Head of Global Development at Elan. His responsibilities include, but are not limited to clinical development, biometrics, regulatory, CMC, QA, safety-and-risk management, clinical operations and medical affairs. Previously he served as head of Onclave Therapeutics, a wholly Elan-owned oncology biotech company.
He lectures extensively on global health and biopharmaceutical issues with particular focus on Emerging Markets (e.g. India, China, Latin America, Singapore, Middle East, South East Asia and Africa). He served as editor and co-author of Global Clinical Trials: Effective Implementation and Management (Elsevier, 2011), a textbook designed to help researchers develop and implement effective and ethical international clinical trials. Dr. Bairu is also editor/co-author of Global Clinical Trials Playbook: Management and Implementation (Elsevier, 2012), and Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization (Elsevier, 2013).
Prior to joining Elan, Dr. Bairu worked at Genentech for more than five years in a number of managed care, medical and commercial (Oncology, Immunology, and Cardiovascular) roles. He served as managed care Medical Director for Fremont Health Corporation/II before joining Genentech. He served on the board of directors for One World Health, a nonprofit drug development company funded by the Bill and Melinda Gates Foundation and A-Cube, a privately held pharma startup.
In 2013, Dr. Bairu was named to the boards of directors of Dubai-based NewBridge Pharmaceuticals (he also serves as chairman of NewBridge’s science and technology committee), and ADVentura Capital SL, a Barcelona, Spain-based venture capital firm focused on funding and mentoring promising healthcare, IT and GreenTech companies. In 2011, Dr. Bairu joined the advisory board of the China Trials 5, a global clinical trials development summit focusing on China and north Asia. He currently serves as Adjunct Faculty at the University of California San Francisco School of Medicine where he lectures on global clinical trials’ design, development and conduct.
Affiliations and expertise
President and CEO, Speranza Therapeutics, Dublin, Ireland and Chief Medical Officer and Head of Global Development, Elan Pharmaceuticals, Cambridge, MassachusettsRead Global Clinical Trials on ScienceDirect