Clinical Research in Asia
Opportunities and Challenges
Published on 25. May 2012
Book
Hardback
412 pages
978-1-907568-00-8 (ISBN)
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).
Reviews / Votes
"An important contribution to the field of global research ethics." --Doody's Book ReviewsMore details
Series
Language
English
Place of publication
Cambridge
United Kingdom
Publishing group
Elsevier Science & Technology
Target group
Professional and scholarly
Dimensions
Height: 234 mm
Width: 156 mm
Weight
1040 gr
ISBN-13
978-1-907568-00-8 (9781907568008)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
E-Book
05/2012
Woodhead Publishing
€170.00
Available for download
Person
Dr Umakanta Sahoo is Executive Director for Asia Pacific and Managing Director for India at Chiltern, a Contract Research Organisation. He is a bioscience graduate with an MBA and PhD in Management, and has over 17 years of experience in the pharmaceutical industry and CRO sector.
Content
Dedication
List of figures and table
Acknowledgments
List of abbreviations
Preface
About the author
Chapter 1: Clinical research in Asia: a brief overview
Abstract:
1.1 Background
1.2 Global pharmaceutical market
1.3 Clinical research business - a global overview
1.4 CRO services mix
1.5 The clinical research boom in Asia
1.6 Asian country segmentation analysis
1.7 Clinical trials in Asia
1.8 Inspection and data quality
1.9 Clinical research in Asia - SWOT analysis
Chapter 2: Clinical research in Japan
Abstract:
2.1 Background and history
2.2 Clinical research industry in Japan
2.3 The regulatory environment in Japan
2.4 Evolution of Japanese good clinical practice
2.5 Global clinical trials in Japan
2.6 Emerging outsourcing models in Japan
2.7 Japan's international strategic outlook
2.8 Future outlook
Chapter 3: Clinical research in India
Abstract:
3.1 Pharmaceutical industry background
3.2 History of clinical research in India
3.3 Evolution of clinical research in India
3.4 Regulatory environment in India
3.5 Clinical trial approval
3.6 Difference between ICH-GCP and Indian GCP
3.7 Regulatory inspections in India
3.8 Clinical research in India: PESTLE analysis
3.9 Future outlook
Chapter 4: Clinical research in China
Abstract:
4.1 Pharmaceutical market
4.2 Pharmaceutical investments in China
4.3 China's healthcare system
4.4 Healthcare delivery system
4.5 The importance of traditional medicine in modern healthcare
4.6 China's CRO market
4.7 Clinical trials in China
4.8 Accreditation of clinical trial sites in China
4.9 Clinical research in China - environmental analysis
4.10 Future outlook
Chapter 5: Clinical research in South Korea
Abstract:
5.1 Pharmaceutical industry overview
5.2 CRO market in South Korea
5.3 Clinical trial environment
5.4 Evolution of GCP in South Korea
5.5 Clinical trials in South Korea
5.6 Accreditation of medical centres
5.7 Environmental analysis
5.8 Future outlook
Chapter 6: Clinical research in Taiwan
Abstract:
Chapter 7: Clinical research in Singapore
Abstract:
7.1 Overview of the pharmaceutical industry in Singapore
7.2 Pharmaceutical investments in Singapore
7.3 Governing authority and regulatory structure
7.4 Healthcare system in Singapore
7.5 Clinical research in Singapore
7.6 CRO market
7.7 Clinical trials in Singapore
7.8 Evolution of GCP in Singapore
7.9 Role of clinical trial resource centre
7.10 Environmental analysis
7.11 Clinical trial challenges
7.12 Future outlook
Chapter 8: Clinical research in Thailand
Abstract:
8.1 Pharmaceutical industry in Thailand
8.2 The pharmaceutical regulatory environment
8.3 Pharmaceutical market
8.4 Clinical research in Thailand
8.5 CRO market in Thailand
8.6 Hospital systems in Thailand
8.7 Conducting clinical trials in Thailand
8.8 Clinical trials in Thailand
8.9 Environmental analysis
8.10 Future outlook
Chapter 9: Clinical research in Malaysia
Abstract:
9.1 Pharmaceutical industry overview
9.2 Pharmaceutical market
9.3 Pharmaceutical regulation
9.4 Healthcare systems in Malaysia
9.5 Clinical trial environment
9.6 Regulatory environment in Malaysia
9.7 Evolution of Malaysian GCP
9.8 CRO market in Malaysia
9.9 Clinical trials in Malaysia
9.10 Registration of clinical trials
9.11 Challenges and future outlook
Chapter 10: Clinical research in Hong Kong
Abstract:
10.1 Background and history
10.2 Pharmaceutical industry in Hong Kong
10.3 Healthcare system in Hong Kong
10.4 Clinical trials in Hong Kong
10.5 The regulatory environment
10.6 Clinical trials in Hong Kong
10.7 Environmental analysis
10.8 Future outlook
Chapter 11: Clinical research in the Philippines, Indonesia Vietnam
Abstract:
11.1 Clinical research in the Philippines
11.2 Clinical research in Indonesia
11.3 Clinical research in Vietnam
Chapter 12: Conclusions
Abstract:
12.1 PESTLE analysis
12.2 Political environment
12.3 Economic environment
12.4 Socio-cultural forces
12.5 Technological factors
12.6 Legal environment
12.7 Other environmental factors
12.8 Strategic issues for the CRO industry
12.9 Future outlook
Bibliography
Index
List of figures and table
Acknowledgments
List of abbreviations
Preface
About the author
Chapter 1: Clinical research in Asia: a brief overview
Abstract:
1.1 Background
1.2 Global pharmaceutical market
1.3 Clinical research business - a global overview
1.4 CRO services mix
1.5 The clinical research boom in Asia
1.6 Asian country segmentation analysis
1.7 Clinical trials in Asia
1.8 Inspection and data quality
1.9 Clinical research in Asia - SWOT analysis
Chapter 2: Clinical research in Japan
Abstract:
2.1 Background and history
2.2 Clinical research industry in Japan
2.3 The regulatory environment in Japan
2.4 Evolution of Japanese good clinical practice
2.5 Global clinical trials in Japan
2.6 Emerging outsourcing models in Japan
2.7 Japan's international strategic outlook
2.8 Future outlook
Chapter 3: Clinical research in India
Abstract:
3.1 Pharmaceutical industry background
3.2 History of clinical research in India
3.3 Evolution of clinical research in India
3.4 Regulatory environment in India
3.5 Clinical trial approval
3.6 Difference between ICH-GCP and Indian GCP
3.7 Regulatory inspections in India
3.8 Clinical research in India: PESTLE analysis
3.9 Future outlook
Chapter 4: Clinical research in China
Abstract:
4.1 Pharmaceutical market
4.2 Pharmaceutical investments in China
4.3 China's healthcare system
4.4 Healthcare delivery system
4.5 The importance of traditional medicine in modern healthcare
4.6 China's CRO market
4.7 Clinical trials in China
4.8 Accreditation of clinical trial sites in China
4.9 Clinical research in China - environmental analysis
4.10 Future outlook
Chapter 5: Clinical research in South Korea
Abstract:
5.1 Pharmaceutical industry overview
5.2 CRO market in South Korea
5.3 Clinical trial environment
5.4 Evolution of GCP in South Korea
5.5 Clinical trials in South Korea
5.6 Accreditation of medical centres
5.7 Environmental analysis
5.8 Future outlook
Chapter 6: Clinical research in Taiwan
Abstract:
Chapter 7: Clinical research in Singapore
Abstract:
7.1 Overview of the pharmaceutical industry in Singapore
7.2 Pharmaceutical investments in Singapore
7.3 Governing authority and regulatory structure
7.4 Healthcare system in Singapore
7.5 Clinical research in Singapore
7.6 CRO market
7.7 Clinical trials in Singapore
7.8 Evolution of GCP in Singapore
7.9 Role of clinical trial resource centre
7.10 Environmental analysis
7.11 Clinical trial challenges
7.12 Future outlook
Chapter 8: Clinical research in Thailand
Abstract:
8.1 Pharmaceutical industry in Thailand
8.2 The pharmaceutical regulatory environment
8.3 Pharmaceutical market
8.4 Clinical research in Thailand
8.5 CRO market in Thailand
8.6 Hospital systems in Thailand
8.7 Conducting clinical trials in Thailand
8.8 Clinical trials in Thailand
8.9 Environmental analysis
8.10 Future outlook
Chapter 9: Clinical research in Malaysia
Abstract:
9.1 Pharmaceutical industry overview
9.2 Pharmaceutical market
9.3 Pharmaceutical regulation
9.4 Healthcare systems in Malaysia
9.5 Clinical trial environment
9.6 Regulatory environment in Malaysia
9.7 Evolution of Malaysian GCP
9.8 CRO market in Malaysia
9.9 Clinical trials in Malaysia
9.10 Registration of clinical trials
9.11 Challenges and future outlook
Chapter 10: Clinical research in Hong Kong
Abstract:
10.1 Background and history
10.2 Pharmaceutical industry in Hong Kong
10.3 Healthcare system in Hong Kong
10.4 Clinical trials in Hong Kong
10.5 The regulatory environment
10.6 Clinical trials in Hong Kong
10.7 Environmental analysis
10.8 Future outlook
Chapter 11: Clinical research in the Philippines, Indonesia Vietnam
Abstract:
11.1 Clinical research in the Philippines
11.2 Clinical research in Indonesia
11.3 Clinical research in Vietnam
Chapter 12: Conclusions
Abstract:
12.1 PESTLE analysis
12.2 Political environment
12.3 Economic environment
12.4 Socio-cultural forces
12.5 Technological factors
12.6 Legal environment
12.7 Other environmental factors
12.8 Strategic issues for the CRO industry
12.9 Future outlook
Bibliography
Index