Global Clinical Trials Playbook

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.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.

• Section 1: Clinical Trials1. Introduction2. Global Clinical Trials: Study Design and Planning3. Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials: African Perspectives4. Clinical Trial Sites Capabilities: Standard Operating Procedure Implementation in Effective African Models5. How to Select and Oversee Contract Research Organizations 6. The How-To of Global Clinical Trial Forecasting, Budgeting and Project ManagementSection 2: Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets7. Lessons Learned in India8. Lessons Learned in China9. Lessons Learned in Eastern Europe10. Lessons Learned in Singapore11. Lessons Learned in TurkeySection 3: Regulatory Capacity12. Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials: Taiwan’s Experience as an ExampleSection 4: How to Build and Enhance Pharmacovigilance and Risk Management Capacity and Capability13. Pharmacovigilance and Risk ManagementSection 5: Electronic Data Capture14. Setting up Electronic Data Capture CapabilitiesSection 6: Ethics, Human Resources, and Intellectual Property15. Ethics and International Review Board Capacity BuildingSection 7: Quality Assurance and Data Management16. Clinical Quality Assurance and Data Management Appendix A - Sample Protocol TemplateAppendix B - Sample Informed Consent FormAppendix C - Sample Case Report FormAppendix D - Sample Statistical Analysis PlanAppendix E - Case Report Form Versioning PolicyAppendix F - Checklist for Study Close-outAppendix G - Financial Disclosure Form

"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