Beschreibung:
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. 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
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. 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
1;Front Cover;12;Dedication;33;Global Clinical Trials;44;Copyright;55;Contents;66;About the Editiors;147;Foreword;168;Contributors;189;Section 1 -Overview;229.1;Chapter 1 -Background;249.1.1;1.1 -Introduction;249.1.2;1.2 -Growth of Global Clinical Trials;259.1.3;1.3 -Drivers of Globalization;279.1.4;1.4 -Issues of Globalization;289.1.5;1.5 -Control and Inspections of Foreign Sites;299.1.6;1.6 -Ethnic and Genetic Differences;299.1.7;1.7 -Usability of International Clinical Data in Regulatory Filings;309.1.8;1.8 -World Health Organization Prequalification Process;339.1.9;References;389.2;Chapter 2 - Bioethical Considerations in Global Clinical Trials;409.2.1;2.1 -Introduction;409.2.2;2.2 -Ethical Standards and International Law;429.2.3;2.3 -Codes of Conduct;439.2.4;2.4 -Good Clinical Practice;499.2.5;References;509.3;Chapter 3 - United States Regulations;529.3.1;3.1 -Overview of the Food and Drug Administration in the USA;529.3.2;3.2 -The FDA's Legal Authority;589.3.3;3.3 -Requirements for Approval;599.3.4;3.4 -Use of Foreign Clinical Data by the FDA;639.3.5;References;669.4;Chapter 4 Chapter 4 -European Union Regulations;689.4.1;4.1 -Overview of the European Union;689.4.2;4.2 -Overview of the European Medicines Agency;699.4.3;4.3 -EMA Committees;729.4.4;4.4 -Regulations and Guidance Related to Product Authorization;729.4.5;4.5 -EMA Good Clinical Practices;749.4.6;4.6 -Requirements for Marketing Authorization Applications;789.4.7;4.7 -Medical Device Clinical Trial Requirements;809.4.8;References;839.5;Chapter 5 - Japanese Regulations;849.5.1;5.1 -Introduction;859.5.2;5.2 -Documents Required for Application;859.5.3;5.3 -Review Process for New Drug Applications;929.5.4;5.4 -Required Surveys;939.5.5;5.5 -Contents Reviewed in the Drug Approval Application;949.5.6;5.6 -Differences Between J-GCP and ICH-GCP;959.5.7;5.7 -Notification of the Intent to Perform Clinical Trials;969.5.8;References;10510;Section 2 -Bioethical Considerations in Global Clinical Trials;10810.1;Chapter 6 - Indian Regulatory Framework;11010.1.1;6.1 -Introduction;11110.1.2;6.2 -Regulatory Hierarchy;11310.1.3;6.3 -Central Drugs Standard Control Organization;11410.1.4;6.4 -Norms and Regulations for the Conduct of Global Trials;11610.1.5;6.5 -Obtaining Permission for Conducting a Clinical Trial;12510.1.6;6.6 -Health Ministry's Screening Committee Clearance;12610.1.7;6.7 -Clinical Trials Registration;12810.1.8;6.8 -Special Considerations;12910.1.9;6.9 -New Initiatives;13710.1.10;6.10 -Conclusion;13810.1.11;Acknowledgments;13810.1.12;References;13810.2;Chapter 7 -Clinical Trials in India;14010.2.1;7.1 -Introduction;14110.2.2;7.2 -India: Background;14110.2.3;7.3 -Demographics;14210.2.4;7.4 -Disease Profile;14310.2.5;7.5 -Healthcare System;14510.2.6;7.6 -Indian Pharmaceutical Market;14610.2.7;7.7 -India's Changing Intellectual Property Rights Environment;14710.2.8;7.8 -Regulatory Environment;14810.2.9;7.9 -Ethics Committee Approval;15710.2.10;7.10 -Good Clinical Practice In India;15910.2.11;7.11 -FDA Audit and Inspection: Outcomes and Findings;16110.2.12;7.12 -Language;16110.2.13;7.13 -India's Clinical Trial Sector;16210.2.14;7.14 -Access to Patients;16510.2.15;7.15 -Access to Investigators;16710.2.16;7.16 -Access to Clinical Sites;16810.2.17;7.17 -Working Effectively with Indian Clinical Trial Sites;16910.2.18;7.18 -Pharmacovigilance;17110.2.19;7.19 -Data Management Services;17210.2.20;7.20 -Clinical Trial Supply Management in India;17310.2.21;7.21 -Cost of Clinical Trial Services;17310.2.22;7.22 -Clinical Trial Staff;17410.2.23;7.23 -Conducting Trials in India;17510.2.24;7.24 -Importance of India's Clinical Trials Sector;17610.2.25;References;17710.3;Chapter 8 -Chinese Regulatory Framework;18010.3.1;8.1 -Overview of Drug Administration in China;18010.3.2;8.2 -Drug Registration;18310.3.3;References;18910.4;Chapter 9 -Clinical Trials in China;19010.4.1;9.1 -Introduction;19110.4