COVID-19 Update: We are currently shipping orders daily. However, due to transit disruptions in some geographies, deliveries may be delayed. To provide all customers with timely access to content, we are offering 50% off Science and Technology Print & eBook bundle options. Terms & conditions.
Global Clinical Trials - 1st Edition - ISBN: 9780123815378, 9780123815385

Global Clinical Trials

1st Edition

Effective Implementation and Management

Editors: Richard Chin Menghis Bairu
Hardcover ISBN: 9780123815378
Paperback ISBN: 9780128103555
eBook ISBN: 9780123815385
Imprint: Academic Press
Published Date: 23rd May 2011
Page Count: 522
Sales tax will be calculated at check-out Price includes VAT/GST
Price includes VAT/GST

Institutional Subscription

Secure Checkout

Personal information is secured with SSL technology.

Free Shipping

Free global shipping
No minimum order.


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.

Key Features

  • 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

Table of Contents

About the Editors



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




No. of pages:
© Academic Press 2011
23rd May 2011
Academic Press
Hardcover ISBN:
Paperback ISBN:
eBook ISBN:

About the Editors

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, USA

Menghis Bairu

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, Massachusetts


"...can be considered a manual on how an ethical global clinical trial should be conducted....a landmark publication; it likely will stand as a standard reference book for global clinical trials for many years to come." --Journal of the American Medical Association, May 2012

"Global Clinical Trials: Effective Implementation and Management” is probably the most comprehensive book written to date on the topic…The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research." --Journal of Clinical Research Best Practices, May 2012

Ratings and Reviews