Key Features
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Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries
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Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting
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Case studies outline successes, failures, lessons learned and prospects for future collaboration
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Includes country-specific guidelines for the most utilized countries
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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.
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
