Global Clinical Trials Playbook

Global Clinical Trials Playbook, 1st Edition

Capacity and Capability Building

Global Clinical Trials Playbook, 1st Edition,Menghis Bairu,Richard Chin,ISBN9780124157873

Bairu   &   Chin   

Academic Press




276 X 216

An up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries

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Key Features

  • Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world
  • Provides real world international examples which illustrate the practical translation of principles
  • Includes forms, templates, and additional references for standardization in a number of global scenarios


Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium.

Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries.  This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. 


Professionals in biotechnology and pharmaceutical companies, government, NGOs, contract research organizations and foundations including physicians, regulators, safety officers, clinical coordinators, data managers, and business managers who are planning and executing clinical trials in developing countries

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

View additional works by Menghis Bairu

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

View additional works by Richard Chin

Global Clinical Trials Playbook, 1st Edition


International Editorial Advisors


Section 1 Clinical Trials

Chapter 1. Introduction

Chapter 2. Global Clinical Trials


Principles of Clinical Study Design


Chapter 3. Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials


Status of Clinical Trials in Africa

Site Management Structures

Current Funding Models and Impact on Implementation of Studies

Building Additional Capacity

Establishing New Sites


Chapter 4. Clinical Trial Sites Capabilities


Role of Standard Operating Procedures in Clinical Research

Standard Operating Procedures, Policies, Guidelines, and Study-Specific Procedures

Suggested List of Standard Operating Procedures

Logistics Associated with Standard Operating Procedure Implementation



Chapter 5. How to Select and Oversee Contract Research Organizations


Perspective of Working with Global and Niche Contract Research Organizations

Understanding Your Options when Outsourcing an Overseas Trial

Comparing the Capabilities of Global and Niche Contract Research Organizations to Support Clinical Trials

Assessing the Benefits of International Reach Versus Local Knowledge

Examining Quality and Relationship Management to Finalize Contract Research Organization Selection


Chapter 6. The How-To of Global Clinical Trial Forecasting, Budgeting, and Project Management

Recent Trends in Clinical Trials

Clinical Trial Forecasting

Clinical Trial Budgeting

Clinical Trial Project Management


Section 2 Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets

Chapter 7. Lessons Learned in India


India’s Healthcare System

India’s Clinical Trials Sector

ECCRO’s Approach to Site Development and Support in India


Chapter 8. Lessons Learned in China


Advantages of Conducting Clinical Trials in China

Challenges to Conducting Global Clinical Trials in China

Regulatory Approval

How Can China Participate in Global Multicenter Trials?

Some Practical Aspects of Global Studies in China

Cost of Clinical Trials in China

Clinical Trial Monitoring in China

Clinical Trials Outsourcing in China

Intellectual Property Rights




Chapter 9. Lessons Learned in Eastern Europe



Role of the Head of the Department

Site Selection

Specifics of Randomized Controlled Trials in Alzheimer’s Disease

Preventive Measures

Case Studies


Chapter 10. Lessons Learned in Singapore


Overview of the Healthcare System in Singapore

Role of Government

Singapore as a Clinical Trial Center in Asia Pacific

Clinical Trial Site Capabilities in Singapore

Conclusion and Future Aspects


Chapter 11. Lessons Learned in Turkey


Overview of the Turkish Healthcare and Pharma Sector

Pharmaceutical Industry

Clinical Trials

Clinical Trials in Turkey During the Transition Period

Clinical Trial Logistics

Conclusion and Lessons Learned


Section 3 Regulatory Capacity

Chapter 12. Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials

Drug Regulation: An Instrument for Public Assurance of Drug Safety and Efficacy

Dimensions of Regulatory Capacity

Globalization of Clinical Research and International Conference on Harmonisation: Sharing Expertise for Capacity Building

Regulation of Clinical Trials in Developing Countries

Ethics Committees as Co-regulators



Section 4 How to Build and Enhance Pharmacovigilance and Risk Management Capacity and Capability

Chapter 13. Pharmacovigilance and Risk Management

Definition of Pharmacovigilance and Risk Management

The Importance of Implementing a Systematic Pharmacovigilance Approach in Global Clinical Trials

Operational Overview of Pharmacovigilance

Components and Capabilities of a Complete Pharmacovigilance System

Pharmacovigilance Policies, Regulations, and Guidance Documents

Organizational Structure of a Pharmacovigilance Department

Role of the Medical Monitor

Roles and Responsibilities of the Pharmacovigilance Team

Appropriate Facilities for Pharmacovigilance

Safety Databases

Safety Case Processing and Review

Global Safety Reporting

Safety Data Review and Assessment

Managing Risk

Outsourcing While Building Pharmacovigilance Capacity

General Considerations and Conclusions


Section 5 Electronic Data Capture

Chapter 14. Setting Up Electronic Data Capture Capabilities


The Role of Data Management in Clinical Trials

Opportunities and Challenges When Outsourcing Data Management

Setting Up Electronic Data Capture Capabilities in an Emerging Country

Good Clinical Data Management Practices

Appendix 1

Appendix 2

Appendix 3

Appendix 4


Section 6 Ethics, Human Resources, and Intellectual Property

Chapter 15. Ethics and Institutional Review Board Capacity Building


Ethical Guidelines

Fundamental Issues



Section 7 Quality Assurance and Data Management

Chapter 16. Clinical Quality Assurance and Data Management


Clarifying the Terminology

Basic Quality Requirements

The Case for a Good Clinical Practice Quality System

Clinical Quality Assurance

Good Clinical Practice Quality Audits

Good Clinical Practice Quality Organization

Good Clinical Practice Inspection Readiness



Section 8 Appendices

APPENDIX A. Sample Protocol Template

APPENDIX B. Sample Informed Consent Form

Research Subject Informed Consent Form

1 Purpose of this Research Study

2 Procedures

3 Possible Risks or Discomfort

4 Ownership and Documentation of Specimens

5 Possible Benefits

6 Financial Considerations

7 Available Treatment Alternatives

8 Available Medical Treatment for Adverse Experiences

9 Confidentiality

10 Termination of Research Study

11 Available Sources of Information

12 Authorization

APPENDIX C. Sample Case Report Form

APPENDIX D. Sample Statistical Analysis Plan

Approval Sign-Off

Statistical Analysis Plan

1 Introduction

2 Objectives

3 Study Design

4 Abbreviations and Definitions

5 Statistical Methods

6 Planned Tables, Listings and Graphs

7 References

8 Appendices

APPENDIX E. Case Report Form Versioning Policy

APPENDIX F. Checklist for Study Close-out

APPENDIX G. Financial Disclosure Form


Color Plates

Quotes and reviews

"Contributors mostly from outside of Europe and the US explore various elements required for successfully implementing clinical trials in poor countries that will be used as evidence to license drugs in rich countries." --Reference and Research Book News, August 2013

"The book brings together a panoply of academics, registration professionals, safety officers and other experts from the pharmaceutical industry and CROs… [and] uses real-life examples to present the tools available to build and enhance human capacity in order to execute clinical trials throughout the world, and is recommended for anybody interested in expanding their knowledge of international clinical trials." --Samedan LTD Pharmaceutical Publishers, Autumn 2012

"Global Clinical Trials: Effective Implementation and Management is probably the most comprehensive book written to date on the topic. In 2008, 97 (80%) of 121 FDA marketing applications for drug and biological products included non-U.S. data, including 10 (8%) with no U.S. data. The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research" --Clinical Research Best Practices

"This is indeed a valuable resource with a broad range of regional experiences in clinical trials and touching a wide array of topics increasing the potential of target readers. I have truly found it quite informative." --Dr. Michael Makanga, Director South-South Cooperation and Head of Africa Office, European and Developing Countries Clinical Trials Partnership (EDCTP), South Africa

"Global Clinical Trials Playbook is a treatise in self-learning, and a must read for researchers in academia, CROs, and NGOs involved in funding and conducting clinical trials. It is a vital reference for those interested in capacity building in clinical research, especially in developing countries." --Professor S. D. Seth, MD, FAMS, FNASc, FIPS, FCAI, FISCD, Advisor of Clinical Trials Registry - India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India

"This is an important book that comprehensively addresses capacity building across the globe. The breadth of the book and the broad array of geographies covered are impressive. This is a major publication that will push the field forward." --Dr. Dan Zhang, MD, PhD, Chairman and CEO of Fountain Medical Group, Shangai, China

"Dr. Bairu and colleagues have produced the definitive reference guide to undertaking clinical trials around the world. I am sure that the Global Clinical Trials Playbook will instantly become an indispensable resource for funders and organisers of clinical trials who wish to stay up to date with the latest thinking in this fast moving field." --Dr. Rubin Minhas, M.B.Ch.B, Editor-in-Chief: Clinical Evidence, Best Practice and Clinical Director, BMJ Evidence Centre

"This book covers a broad range of topics important in global clinical trials and will be a welcome and comprehensive resource for professionals who are engaged in clinical trial related capacity building. It is a practical guide to conduct clinical trials in the new and uprising parts of the drug development world including Eastern Europe, Turkey, Singapore, India and China. The book goes hand in hand with global efforts to develop one global training concept for global drug development, the PharmaTrain Project. Learning by reading and doing for improved competency." --Fritz R. Bühler, Coordinator of IMI PharmaTrain, University of Basel, Switzerland Carl C. Peck, University of California San Francisco, UCSF, USA.Both Founders of the European, American and Chinese Courses in Drug Development and Regulatory Sciences

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