Global Clinical Trials book cover

Global Clinical Trials

Effective Implementation and Management

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.

Audience

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.

Hardbound, 522 Pages

Published: May 2011

Imprint: Academic Press

ISBN: 978-0-12-381537-8

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


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

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