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Clinical trials are research programs conducted with patients to evaluate a new medical treatment, drug, or device. Cost and timeline pressures, along with growing interest in diseases affecting developing nations, have lead to an increasing number of clinical trials lead by pharmaceutical companies, academics, and NGOs being conducted in developing countries. Within the next decade, it is estimated that more than 50% of clinical trials will be conducted overseas. Developing countries offer lower cost, rapid enrolment, and large populations. They also present greater logistical challenges. 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. Edited by Richard Chin, CEO, Oxigene San Francisco, CA, USA and Menghis Bairu Table of Contents: 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