Clinical Research in Asia

Clinical Research in Asia

by U Sahoo
Released May 2012
Publisher(s): Woodhead Publishing
ISBN: 9781908818133

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Book description

Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis).

  • Analysis from a leading and highly respected professional in the sector
  • An overview of country-specific regulatory environments
  • Discussion of challenges and solutions for clinical research

Table of contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Dedication
  5. Copyright
  6. List of figures and table
  7. Acknowledgments
  8. List of abbreviations
  9. Preface
  10. About the author
  11. Chapter 1: Clinical research in Asia: a brief overview
    1. Abstract:
    2. 1.1 Background
    3. 1.2 Global pharmaceutical market
    4. 1.3 Clinical research business – a global overview
    5. 1.4 CRO services mix
    6. 1.5 The clinical research boom in Asia
    7. 1.6 Asian country segmentation analysis
    8. 1.7 Clinical trials in Asia
    9. 1.8 Inspection and data quality
    10. 1.9 Clinical research in Asia – SWOT analysis
  12. Chapter 2: Clinical research in Japan
    1. Abstract:
    2. 2.1 Background and history
    3. 2.2 Clinical research industry in Japan
    4. 2.3 The regulatory environment in Japan
    5. 2.4 Evolution of Japanese good clinical practice
    6. 2.5 Global clinical trials in Japan
    7. 2.6 Emerging outsourcing models in Japan
    8. 2.7 Japan’s international strategic outlook
    9. 2.8 Future outlook
  13. Chapter 3: Clinical research in India
    1. Abstract:
    2. 3.1 Pharmaceutical industry background
    3. 3.2 History of clinical research in India
    4. 3.3 Evolution of clinical research in India
    5. 3.4 Regulatory environment in India
    6. 3.5 Clinical trial approval
    7. 3.6 Difference between ICH-GCP and Indian GCP
    8. 3.7 Regulatory inspections in India
    9. 3.8 Clinical research in India: PESTLE analysis
    10. 3.9 Future outlook
  14. Chapter 4: Clinical research in China
    1. Abstract:
    2. 4.1 Pharmaceutical market
    3. 4.2 Pharmaceutical investments in China
    4. 4.3 China’s healthcare system
    5. 4.4 Healthcare delivery system
    6. 4.5 The importance of traditional medicine in modern healthcare
    7. 4.6 China’s CRO market
    8. 4.7 Clinical trials in China
    9. 4.8 Accreditation of clinical trial sites in China
    10. 4.9 Clinical research in China – environmental analysis
    11. 4.10 Future outlook
  15. Chapter 5: Clinical research in South Korea
    1. Abstract:
    2. 5.1 Pharmaceutical industry overview
    3. 5.2 CRO market in South Korea
    4. 5.3 Clinical trial environment
    5. 5.4 Evolution of GCP in South Korea
    6. 5.5 Clinical trials in South Korea
    7. 5.6 Accreditation of medical centres
    8. 5.7 Environmental analysis
    9. 5.8 Future outlook
  16. Chapter 6: Clinical research in Taiwan
    1. Abstract:
  17. Chapter 7: Clinical research in Singapore
    1. Abstract:
    2. 7.1 Overview of the pharmaceutical industry in Singapore
    3. 7.2 Pharmaceutical investments in Singapore
    4. 7.3 Governing authority and regulatory structure
    5. 7.4 Healthcare system in Singapore
    6. 7.5 Clinical research in Singapore
    7. 7.6 CRO market
    8. 7.7 Clinical trials in Singapore
    9. 7.8 Evolution of GCP in Singapore
    10. 7.9 Role of clinical trial resource centre
    11. 7.10 Environmental analysis
    12. 7.11 Clinical trial challenges
    13. 7.12 Future outlook
  18. Chapter 8: Clinical research in Thailand
    1. Abstract:
    2. 8.1 Pharmaceutical industry in Thailand
    3. 8.2 The pharmaceutical regulatory environment
    4. 8.3 Pharmaceutical market
    5. 8.4 Clinical research in Thailand
    6. 8.5 CRO market in Thailand
    7. 8.6 Hospital systems in Thailand
    8. 8.7 Conducting clinical trials in Thailand
    9. 8.8 Clinical trials in Thailand
    10. 8.9 Environmental analysis
    11. 8.10 Future outlook
  19. Chapter 9: Clinical research in Malaysia
    1. Abstract:
    2. 9.1 Pharmaceutical industry overview
    3. 9.2 Pharmaceutical market
    4. 9.3 Pharmaceutical regulation
    5. 9.4 Healthcare systems in Malaysia
    6. 9.5 Clinical trial environment
    7. 9.6 Regulatory environment in Malaysia
    8. 9.7 Evolution of Malaysian GCP
    9. 9.8 CRO market in Malaysia
    10. 9.9 Clinical trials in Malaysia
    11. 9.10 Registration of clinical trials
    12. 9.11 Challenges and future outlook
  20. Chapter 10: Clinical research in Hong Kong
    1. Abstract:
    2. 10.1 Background and history
    3. 10.2 Pharmaceutical industry in Hong Kong
    4. 10.3 Healthcare system in Hong Kong
    5. 10.4 Clinical trials in Hong Kong
    6. 10.5 The regulatory environment
    7. 10.6 Clinical trials in Hong Kong
    8. 10.7 Environmental analysis
    9. 10.8 Future outlook
  21. Chapter 11: Clinical research in the Philippines, Indonesia Vietnam
    1. Abstract:
    2. 11.1 Clinical research in the Philippines
    3. 11.2 Clinical research in Indonesia
    4. 11.3 Clinical research in Vietnam
  22. Chapter 12: Conclusions
    1. Abstract:
    2. 12.1 PESTLE analysis
    3. 12.2 Political environment
    4. 12.3 Economic environment
    5. 12.4 Socio-cultural forces
    6. 12.5 Technological factors
    7. 12.6 Legal environment
    8. 12.7 Other environmental factors
    9. 12.8 Strategic issues for the CRO industry
    10. 12.9 Future outlook
  23. Bibliography
  24. Index

Product information

  • Title: Clinical Research in Asia
  • Author(s): U Sahoo
  • Release date: May 2012
  • Publisher(s): Woodhead Publishing
  • ISBN: 9781908818133