Global clinical trials : effective implementation and management / Richard Chin, Menghis Bairu [editors].

Format:

Book

Contributor:

Chin, Richard.

Bairu, Menghis.

Language:

English

Subjects (All):

Clinical trials.

Physical Description:

xx, 501 pages : illustrations (some color) ; 24 cm

Place of Publication:

London ; Waltham, MA : Academic Press, 2011.

Summary:

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.

Contents:

Section 1 Overview

1 Background 3

1.1 Introduction 3

1.2 Growth of Global Clinical Trials 4

1.3 Drivers of Globalization 6

1.4 Issues of Globalization 7

1.5 Control and Inspections of Foreign Sites 8

1.6 Ethnic and Genetic Differences 8

1.7 Usability of International Clinical Data in Regulatory Filings 9

1.8 World Health Organization Prequalification Process 12

References 17

2 Bioethical Considerations in Global Clinical Trials 19

2.1 Introduction 19

2.2 Ethical Standards and International Law 21

2.3 Codes of Conduct 22

2.4 Good Clinical Practice 28

References 29

3 United States Regulations 31

3.1 Overview of the Food and Drug Administration in the USA 31

3.2 The FDA's Legal Authority 37

3.3 Requirements for Approval 38

3.4 Use of Foreign Clinical Data by the FDA 42

References 45

4 European Union Regulations 47

4.1 Overview of the European Union 47

4.2 Overview of the European Medicine Agency 48

4.3 EMA Committees 51

4.4 Regulations and Guidance Related to Product Authorization 51

4.5 EMA Good Clinical Practices 53

4.6 Requirements for Marketing Authorization Applications 57

4.7 Medical Device Clinical Trial Requirements 59

References 62

5 Japanese Regulations 63

5.1 Introduction 64

5.2 Documents Required for Application 64

5.3 Review Process for New Drug Applications 71

5.4 Required Surveys 72

5.5 Contents Reviewed in the Drug Approval Application 73

5.6 Differences Between J-GCP and ICH-GCP 74

5.7 Notification of the Intent to Perform Clinical Trials 75

References 84

Section 2 Bioethical Considerations in Global Clinical Trials

6 Indian Regulatory Framework 89

6.1 Introduction 90

6.2 Regulatory Hierarchy 92

6.3 Central Drugs Standard Control Organization 93

6.4 Norms and Regulations for the Conduct of Global Trials 95

6.5 Obtaining Permission for Conducting a Clinical Trial 104

6.6 Health Ministry's Screening Committee Clearance 105

6.7 Clinical Trials Registration 107

6.8 Special Considerations 108

6.9 New Initiatives 116

6.10 Conclusion 117

Acknowledgments 117

References 117

7 Clinical Trials in India 119

7.1 Introduction 120

7.2 India: Background 120

7.3 Demographics 121

7.4 Disease Profile 122

7.5 Healthcare System 124

7.6 Indian Pharmaceutical Market 125

7.7 India's Changing Intellectual Property Rights Environment 126

7.8 Regulatory Environment 127

7.9 Ethics Committee Approval 136

7.10 Good Clinical Practice In India 138

7.11 FDA Audit and Inspection: Outcomes and Findings 140

7.12 Language 140

7.13 India's Clinical Trial Sector 141

7.14 Access to Patients 144

7.15 Access to Investigators 146

7.16 Access to Clinical Sites 147

7.17 Working Effectively with Indian Clinical Trial Sites 148

7.18 Pharmacovigilance 150

7.19 Data Management Services 151

7.20 Clinical Trial Supply Management in India 152

7.21 Cost of Clinical Trial Services 152

7.22 Clinical Trial Staff 153

7.23 Conducting Trials in India 154

7.24 Importance of India's Clinical Trials Sector 155

References 156

8 Chinese Regulatory Framework 159

8.1 Overview of Drug Administration in China 159

8.2 Drug Registration 162

References 168

9 Clinical Trials in China 169

9.1 Introduction 170

9.2 Regulatory Climate 173

9.3 Current Status and Statistics on Clinical Trials 176

9.4 Overview of Investigators and Sites in China 177

9.5 Contract Research Organizations 186

9.6 Challenges and Opportunities 187

References 188

10 Clinical Trials in Taiwan 191

10.1 Introduction 192

10.2 Regulatory Climate 193

10.3 Current Status and Statistics of Clinical Trials 196

10.4 Overview of Investigators and Sites in Taiwan 197

10.5 Contract Research Organizations 199

10.6 Challenges and Opportunities 200

Acknowledgments 203

References 203

11 Clintcal Trials in the Philippines 205

11.1 Introduction 205

11.2 Regulatory Climate 208

11.3 Current Status and Statistics on Clinical Trials 212

11.4 Overview of Investigators and Sites in the Philippines 213

11.5 Challenges and Opportunities 215

References 216

12 Clinical Trials in the Middle East and North Africa 217

12.1 Introduction 217

12.2 Clinical Trial Status 220

12.3 Infrastructure and System of Healthcare 223

12.4 Patient Profile 243

12.5 Challenges and Opportunities 244

References 244

13 Clinical Trials in South Africa 245

13.1 Introduction 245

13.2 Geography 246

13.3 Healthcare System and Infrastructure 247

13.4 Disease Profile 249

13.5 History of Clinical Trials in South Africa 250

13.6 Regulation of Clinical Trials 251

13.7 Ethics Committees 254

13.8 Good Clinical Practice 256

13.9 Clinical Trial Status 257

13.10 Participant Profile 258

13.11 Inspections 260

13.12 Pharmacovigilance 261

13.13 Staffing of Clinical Trials 263

13.14 Logistics 264

13.15 Clinical Trial Industry Associations 266

13.16 Challenges and Opportunities 266

References 268

14 Clinical Trials in Latin America 271

14.1 Introduction 272

14.2 Regulatory Climate 278

14.3 Current Status and Statistics on Clinical Trials 296

14.4 Overview of Investigators and Sites in Latin America 297

14.5 Contract Research Organizations 301

14.6 Challenges and Opportunities 306

References 308

15 Clinical Trials in Central and Eastern Europe 309

15.1 Czech Republic 312

15.2 Hungary 319

15.3 Latvia 322

15.4 Estonia 327

15.5 Poland 333

15.6 Romania 339

15.7 Ukraine 345

15.8 Russia 351

Section 3 Clinical Study Logistics

16 Design of Clinical Trials for Emerging Countries 359

16.1 Introduction 359

16.2 Opportunities 360

16.3 Challenges 363

16.4 Recommendations 367

16.5 Conclusion 380

References 380

17 Study Management 381

17.1 Introduction 382

17.2 Planning and Project Management 388

17.3 Selection, Qualification, and Management of Contract Research Organizations 389

17.4 Central Laboratory Considerations 394

Acknowledgment 400

References 400

18 Study Documents and Logistics 401

18.1 Introduction 402

18.2 Writing the Study Protocol 402

18.3 Writing the Investigator's Brochure 404

18.4 Informed Consent and the Informed Consent Form 407

18.5 Chemistry, Manufacturing, and Controls 410

18.6 Drug Supply and Labeling 412

18.7 Interactive Voice Response Technology 414

18.8 Investigators' Meeting 417

18.9 Electrical Generators and Power Issues 420

18.10 Translations 421

Acknowledgment 422

References 422

19 Clinical Study Conduct and Monitoring 423

19.1 Regulations and Harmonization 424

19.2 Preclinical Study, and Chemistry, Manufacturing, and Control 425

19.3 Phases of Clinical Development 426

19.4 Clinical Study Conduct 429

19.5 Clinical Study Team 430

19.6 Clinical Study Protocol 431

19.7 Case Report Forms 434

19.8 Data and Safety Monitoring Board 435

19.9 Investigational New Drug Application and the Food and Drug Administration 435

19.10 Protecting the Research Subjects 442

19.11 Study Start-Up 448

19.12 Clinical Study Binder 455

19.13 Subject/Patient Recruitment 458

19.14 Site Monitoring Visits 460

19.15 End of Study 463

19.16 Audits and Inspections 466

References 468

20 Data Collection, Data Management, and Electronic Data Capture 471

20.1 Introduction 471

20.2 The Electronic Data Capture Evaluation Team 473

20.3 Electronic Data Capture Vendor Selection 475

20.4 Narrowing the Field: Strategies for Second Round Selection 478

20.5 Final Review 478.

Notes:

Includes bibliographical references and index.

ISBN:

9780123815378

0123815371

OCLC:

676729156