Catalogue


Global clinical trials [electronic resource] : effective implementation and management /
[edited by] Richard Chin, Menghis Bairu.
edition
1st ed.
imprint
Amsterdam ; Boston : Elsevier, 2011.
description
xx, 501 p. : ill., col. maps ; 26 cm.
ISBN
0123815371, 9780123815378
format(s)
Book
More Details
imprint
Amsterdam ; Boston : Elsevier, 2011.
isbn
0123815371
9780123815378
restrictions
Licensed for access by U. of T. users.
abstract
This title explores the great opportunities and challenges which exist in conducting clinical trials in developing countries. --
catalogue key
8122786
 
Includes bibliographical references and index.
A Look Inside
Reviews
Review Quotes
First published in 2011, Global Clinical Trials: Effective Implementation and Management gives a global overview of conducting clinical trials. Its introductory chapter provides bioethical consideration of clinical trials in emerging regions, together with sections on conducting trials in the more traditional regions. US, EU and Japanese regulations are all considered in this section. Although the harmonisation of GCP across the three major developed markets has been a significant advance in drug development and immensely aided the growth of global clinical trials, the International Conference on Harmonisation (ICH) must continue to be developed further. Regulations are not completely harmonised, since every region can add additional requirements, and in many regions these requirements are being added on a regular basis. For this reason it is necessary to keep in touch on an almost daily basis with the regulatory authorities in countries in which you might be wishing to carry out these trials. This is particularly relevant in the developing nations, which are dealt with in subsequent chapters. Bioethical considerations for trials in developing countries are discussed in section 2, concentrating in particular on India, China, Taiwan, Philippines, Middle East and North Africa, South Africa, Latin America and central and eastern Europe. While many readers will be familiar with the regulations and conditions of running clinical trials in eastern Europe and perhaps India, the sections on less well known countries will be of particular use. The final section of the book addresses the logistics of conducting clinical trials in multiple countries. In particular it focuses on the design, management and documentation of clinical trials for emerging countries, and how best these studies can be monitored and conducted. In the final chapter, data collection, data management and electronic data capture are also considered. One particularly important consideration that the book recommends is to recognise the opportunities and challenges in effectively designing and conducting clinical trials in emerging countries. Post-trial design and conduct must be carried out so as to maximise the advantages and above all minimise the risks associated with these emerging countries. The specifics of a trial will certainly influence protocol design and trial planning, and issues relating to conducting clinical trials in emerging regions are normally universally applicable, whether this country be in South America, sub-Saharan Africa or South East Asia. What is particularly impressive in this book is the fine level of detail that is laid out in terms of regulatory affairs and other considerations for virtually every region considered. The authors are drawn from both industry and academia, and address critical issues often seen in global clinical trials. The scope is comprehensive, covering virtually every continent. The book is impressively up-to-date, with references dating up to the end of 2010. With an increasing number of clinical trials being conducted on a global basis this book is very timely, particularly because studies in developing countries often pose specific challenges, so advice on addressing these will be particularly welcome to the clinical trial community. Global Clinical Trials may prove to be a landmark publication and a standard reference book for many years to come. The only reservation one might have is that regulations are constantly evolving, so its coverage may soon become out-of-date. We would certainly expect and indeed look forward to future, updated editions. Found at: http://www.samedanltd.com/magazine/11/issue/168/article/3198
"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
"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
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Summaries
Bowker Data Service Summary
This title explores the great opportunities and challenges which exist in conducting clinical trials in developing countries.
Main Description
A comprehensive guide to the design and development of effective clinical trails in various countries Foreword by David Feigel, former Head of CDRH at FDA Prominent chapter authors, including the Drug Controller General of India 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 led pharmaceutical companies, academics, and NGOs to conduct increasing numbers of clinical trials in developing countries. Current trends indicate that within the next decade, well over 50% of clinical trials will be conducted overseas. Developing countries offer lower costs, rapid enrolment, and large populations. They also, present greater logistical challenges. This book, written by world experts, examines the great opportunities and challenges that exist in conducting clinical trials in developing countries. With specific chapters on India, China, the Middle East, South Africa, Russia, and numerous other countries, this is the first book to provide regulatory and clinical information for each of the major and many of the minor countries in the world. By exploring the various regulations specific to each country and providing insight into 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. In addition, ethical issues are discussed thoroughly, highlighting the significant differences of conducting this work in various jurisdictions. Clear and comprehensive guides to the ins-and-outs of clinical trials in various countries to assist in the design, development, and effectiveness of these trials are presented. Book jacket.
Main 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. 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
Main 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.Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countriesProvides hands-on tools for regulatory and legal requirements and qualification, design, management, and reportingCase studies outline successes, failures, lessons learned and prospects for future collaborationIncludes country-specific guidelines for the most utilized countries
Main 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. 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
Table of Contents
About the Editorsp. xiii
Forewordp. xv
Contributorsp. xvii
Overview
Backgroundp. 3
Introductionp. 3
Growth of Global Clinical Trialsp. 4
Drivers of Globalizationp. 6
Issues of Globalizationp. 7
Control and Inspections of Foreign Sitesp. 8
Ethnic and Genetic Differencesp. 8
Usability of International Clinical Data in Regulatory Filingsp. 9
World Health Organization Prequalification Processp. 12
Referencesp. 17
Bioethical Considerations in Global Clinical Trialsp. 19
Introductionp. 19
Ethical Standards and International Lawp. 21
Codes of Conductp. 22
Good Clinical Practicep. 28
Referencesp. 29
United States Regulationsp. 31
Overview of the Food and Drug Administration in the USAp. 31
The FDA's Legal Authorityp. 37
Requirements for Approvalp. 38
Use of Foreign Clinical Data by the FDAp. 42
Referencesp. 45
European Union Regulationsp. 47
Overview of the European Unionp. 47
Overview of the European Medicine Agencyp. 48
EMA Committeesp. 51
Regulations and Guidance Related to Product Authorizationp. 51
EMA Good Clinical Practicesp. 53
Requirements for Marketing Authorization Applicationsp. 57
Medical Device Clinical Trial Requirementsp. 59
Referencesp. 62
Japanese Regulationsp. 63
Introductionp. 64
Documents Required for Applicationp. 64
Review Process for New Drug Applicationsp. 71
Required Surveysp. 72
Contents Reviewed in the Drug Approval Applicationp. 73
Differences Between J-GCP and ICH-GCPp. 74
Notification of the Intent to Perform Clinical Trialsp. 75
Referencesp. 84
Bioethical Considerations in Global Clinical Trials
Indian Regulatory Frameworkp. 89
Introductionp. 90
Regulatory Hierarchyp. 92
Central Drugs Standard Control Organizationp. 93
Norms and Regulations for the Conduct of Global Trialsp. 95
Obtaining Permission for Conducting a Clinical Trialp. 104
Health Ministry's Screening Committee Clearancep. 105
Clinical Trials Registrationp. 107
Special Considerationsp. 108
New Initiativesp. 116
Conclusionp. 117
Acknowledgmentsp. 117
Referencesp. 117
Clinical Trials in Indiap. 119
Introductionp. 120
India: Backgroundp. 120
Demographicsp. 121
Disease Profilep. 122
Healthcare Systemp. 124
Indian Pharmaceutical Marketp. 125
India's Changing Intellectual Property Rights Environmentp. 126
Regulatory Environmentp. 127
Ethics Committee Approvalp. 136
Good Clinical Practice In Indiap. 138
FDA Audit and Inspection: Outcomes and Findingsp. 140
Languagep. 140
India's Clinical Trial Sectorp. 141
Access to Patientsp. 144
Access to Investigatorsp. 146
Access to Clinical Sitesp. 147
Working Effectively with Indian Clinical Trial Sitesp. 148
Pharmacovigilancep. 150
Data Management Servicesp. 151
Clinical Trial Supply Management in Indiap. 152
Cost of Clinical Trial Servicesp. 152
Clinical Trial Staffp. 153
Conducting Trials in Indiap. 154
Importance of India's Clinical Trials Sectorp. 155
Referencesp. 156
Chinese Regulatory Frameworkp. 159
Overview of Drug Administration in Chinap. 159
Drug Registrationp. 162
Referencesp. 168
Clinical Trials in Chinap. 169
Introductionp. 170
Regulatory Climatep. 173
Current Status and Statistics on Clinical Trialsp. 176
Overview of Investigators and Sites in Chinap. 177
Contract Research Organizationsp. 186
Challenges and Opportunitiesp. 187
Referencesp. 188
Clinical Trials in Taiwanp. 191
Introductionp. 192
Regulatory Climatep. 193
Current Status and Statistics of Clinical Trialsp. 196
Overview of Investigators and Sites in Taiwanp. 197
Contract Research Organizationsp. 199
Challenges and Opportunitiesp. 200
Acknowledgmentsp. 203
Referencesp. 203
Clintcal Trials in the Philippinesp. 205
Introductionp. 205
Regulatory Climatep. 208
Current Status and Statistics on Clinical Trialsp. 212
Overview of Investigators and Sites in the Philippinesp. 213
Challenges and Opportunitiesp. 215
Referencesp. 216
Clinical Trials in the Middle East and North Africap. 217
Introductionp. 217
Clinical Trial Statusp. 220
Infrastructure and System of Healthcarep. 223
Patient Profilep. 243
Challenges and Opportunitiesp. 244
Referencesp. 244
Clinical Trials in South Africap. 245
Introductionp. 245
Geographyp. 246
Healthcare System and Infrastructurep. 247
Disease Profilep. 249
History of Clinical Trials in South Africap. 250
Regulation of Clinical Trialsp. 251
Ethics Committeesp. 254
Good Clinical Practicep. 256
Clinical Trial Statusp. 257
Participant Profilep. 258
Inspectionsp. 260
Pharmacovigilancep. 261
Staffing of Clinical Trialsp. 263
Logisticsp. 264
Clinical Trial Industry Associationsp. 266
Challenges and Opportunitiesp. 266
Referencesp. 268
Clinical Trials in Latin Americap. 271
Introductionp. 272
Regulatory Climatep. 278
Current Status and Statistics on Clinical Trialsp. 296
Overview of Investigators and Sites in Latin Americap. 297
Contract Research Organizationsp. 301
Challenges and Opportunitiesp. 306
Referencesp. 308
Clinical Trials in Central and Eastern Europep. 309
Czech Republicp. 312
Hungaryp. 319
Latviap. 322
Estoniap. 327
Polandp. 333
Romaniap. 339
Ukrainep. 345
Russiap. 351
Clinical Study Logistics
Design of Clinical Trials for Emerging Countriesp. 359
Introductionp. 359
Opportunitiesp. 360
Challengesp. 363
Recommendationsp. 367
Conclusionp. 380
Referencesp. 380
Study Managementp. 381
Introductionp. 382
Planning and Project Managementp. 388
Selection, Qualification, and Management of Contract Research Organizationsp. 389
Central Laboratory Considerationsp. 394
Acknowledgmentp. 400
Referencesp. 400
Study Documents and Logisticsp. 401
Introductionp. 402
Writing the Study Protocolp. 402
Writing the Investigator's Brochurep. 404
Informed Consent and the Informed Consent Formp. 407
Chemistry, Manufacturing, and Controlsp. 410
Drug Supply and Labelingp. 412
Interactive Voice Response Technologyp. 414
Investigators' Meetingp. 417
Electrical Generators and Power Issuesp. 420
Translationsp. 421
Acknowledgmentp. 422
Referencesp. 422
Clinical Study Conduct and Monitoringp. 423
Regulations and Harmonizationp. 424
Preclinical Study, and Chemistry, Manufacturing, and Controlp. 425
Phases of Clinical Developmentp. 426
Clinical Study Conductp. 429
Clinical Study Teamp. 430
Clinical Study Protocolp. 431
Case Report Formsp. 434
Data and Safety Monitoring Boardp. 435
Investigational New Drug Application and the Food and Drug Administrationp. 435
Protecting the Research Subjectsp. 442
Study Start-Upp. 448
Clinical Study Binderp. 455
Subject/Patient Recruitmentp. 458
Site Monitoring Visitsp. 460
End of Studyp. 463
Audits and Inspectionsp. 466
Referencesp. 468
Data Collection, Data Management, and Electronic Data Capturep. 471
Introductionp. 471
The Electronic Data Capture Evaluation Teamp. 473
Electronic Data Capture Vendor Selectionp. 475
Narrowing the Field: Strategies for Second Round Selectionp. 478
Final Reviewp. 478
Indexp. 487
Color Plate Section
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