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Global Clinical Trials
 
 

Global Clinical Trials, 1st Edition

Effective Implementation and Management

 
Global Clinical Trials, 1st Edition,Richard Chin,Menghis Bairu,ISBN9780123815378
 
 
 

Chin   &   Bairu   

Academic Press

9780123815378

9780123815385

528

229 X 152

Comprehensive guide to design and development of effective clinical trials around the world

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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

Description

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.

Readership

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.

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

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

Global Clinical Trials, 1st Edition

Introduction
Section I: Overview
Chapter 1: Background
Overview of Drug Development
History of international clinical trials
Rationale for conducting clinical trials in the developing world
Limitations of conducting clinical trials in the developing world
Chapter 2: Ethics
Background, Codes of Conduct, Responsibility to Patients, Scientific Responsibility, Institutional Review Board (IRB)/Ethics Committee (EC), Requirements of an IRB/EC, Centralized IRBs
Chapter 3: Regulatory and Legal Requirements
Background
International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) and Good Clinical/Manufacturing/Laboratory Practice (GXP) 
Chapter 4: United States Regulations
Background and Requirements for Approval
Food and Drug Administration’s (FDA’s) Legal Authority
Standard of Approval
Chapter 5: Use of Foreign Clinical Data for FDA and EMEA
FDA requirements
EMEA requirements
Quality standards
Difference in patients
Genomic differences
Environmental differences
Differences in treatment patterns
Chapter 6: WHO and prequalification
Chapter 7: Regulatory Filings
Section II: Special Considerations and Regulations in Developing Countries
Chapter 8: South Asia, India, Pakistan, Bangladesh, Nepal
Chapter 9: East Asia, China, Korea, Taiwan
Chapter 10: Africa, Senegal, Kenya, South Africa
Chapter11: Middle East, Egypt, Israel, Saudi Arabia
Chapter 12: Southeast Asian Regulations, Vietnam, Thailand
Chapter 13: South American Regulations, Brazil, Mexico
Chapter 14: Eastern Europe, Russia, Poland, Ukraine
Section III: Clinical Study Logistics
Chapter 15: Design of Clinical Trials for Developing Countries
 Background
 Special Considerations for Developing World
Chapter 16: Study Management, Planning and Project Management, CRO Qualification, Selection, and Management, Outsourcing Strategy, Criteria for CRO Selection, CRO Qualification, Writing Request for Proposals, Negotiating and Writing Contract, CRO Oversight in developing world, CRO Dispute Resolution, Changing CROs, Core Laboratory, Selection and Management, Sample shipment and handling, Clearing samples through customs
Chapter 17: Logistics, Protocol Writing, Investigators Brochure Writing, Informed Consent, CMC, Drug Supply and Labeling, Logistics of clearing customs
 Shipment and cold chain, IVRS, Investigators Meeting, Electrical generators, power issues, Translations
Chapter 18: Site Selection and Capacity Building, Site Selecton, Site Qualification, Site capacity building, , Site Training, Site Closeout 
Chapter 19: Study Conduct and Monitoring, Patient Recruitment, Minimizing Dropout and Drug Compliance, ICH, GCP, and GXP , Medical Monitoring
Clinical Site Monitoring, Safety Monitoring, Regulatory Requirements and Reporting, Data Safety Monitoring Board, Protocol Waivers and Violations
Corrective Action and Shutting Down Sites, Amendments and Administrative Changes 
Chapter 20: Data Collection and Management, Data Management and Quality Plan, Statistical Analysis Plan, Case Report Form Design, Paper CRF
Electronic CRF, Cell phone based data collection, Data Cleaning, Database Locking, Data Analysis
Section IV: Specific Diseases and Types of Studies
Chapter 21: Vaccine trials
Chapter 22: TB Trials
Chapter 23: HIV trials
Chapter 24:  Oncology trials
Chapter 25:  Diabetes trials
Section V: Case Studies
Case Studies

Quotes and reviews

“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.” –Review by Norman M. Goldfarb in Journal of Clinical Research Best Practices, May 2012

 
 
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