Full 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).
Contents
DedicationList of figures and tableAcknowledgmentsList of abbreviationsPrefaceAbout the authorChapter 1: Clinical research in Asia: a brief overviewAbstract:1.1 Background1.2 Global pharmaceutical market1.3 Clinical research business - a global overview1.4 CRO services mix1.5 The clinical research boom in Asia1.6 Asian country segmentation analysis1.7 Clinical trials in Asia1.8 Inspection and data quality1.9 Clinical research in Asia - SWOT analysisChapter 2: Clinical research in JapanAbstract:2.1 Background and history2.2 Clinical research industry in Japan2.3 The regulatory environment in Japan2.4 Evolution of Japanese good clinical practice2.5 Global clinical trials in Japan2.6 Emerging outsourcing models in Japan2.7 Japan's international strategic outlook2.8 Future outlookChapter 3: Clinical research in IndiaAbstract:3.1 Pharmaceutical industry background3.2 History of clinical research in India3.3 Evolution of clinical research in India3.4 Regulatory environment in India3.5 Clinical trial approval3.6 Difference between ICH-GCP and Indian GCP3.7 Regulatory inspections in India3.8 Clinical research in India: PESTLE analysis3.9 Future outlookChapter 4: Clinical research in ChinaAbstract:4.1 Pharmaceutical market4.2 Pharmaceutical investments in China4.3 China's healthcare system4.4 Healthcare delivery system4.5 The importance of traditional medicine in modern healthcare4.6 China's CRO market4.7 Clinical trials in China4.8 Accreditation of clinical trial sites in China4.9 Clinical research in China - environmental analysis4.10 Future outlookChapter 5: Clinical research in South KoreaAbstract:5.1 Pharmaceutical industry overview5.2 CRO market in South Korea5.3 Clinical trial environment5.4 Evolution of GCP in South Korea5.5 Clinical trials in South Korea5.6 Accreditation of medical centres5.7 Environmental analysis5.8 Future outlookChapter 6: Clinical research in TaiwanAbstract:Chapter 7: Clinical research in SingaporeAbstract:7.1 Overview of the pharmaceutical industry in Singapore7.2 Pharmaceutical investments in Singapore7.3 Governing authority and regulatory structure7.4 Healthcare system in Singapore7.5 Clinical research in Singapore7.6 CRO market7.7 Clinical trials in Singapore7.8 Evolution of GCP in Singapore7.9 Role of clinical trial resource centre7.10 Environmental analysis7.11 Clinical trial challenges7.12 Future outlookChapter 8: Clinical research in ThailandAbstract:8.1 Pharmaceutical industry in Thailand8.2 The pharmaceutical regulatory environment8.3 Pharmaceutical market8.4 Clinical research in Thailand8.5 CRO market in Thailand8.6 Hospital systems in Thailand8.7 Conducting clinical trials in Thailand8.8 Clinical trials in Thailand8.9 Environmental analysis8.10 Future outlookChapter 9: Clinical research in MalaysiaAbstract:9.1 Pharmaceutical industry overview9.2 Pharmaceutical market9.3 Pharmaceutical regulation9.4 Healthcare systems in Malaysia9.5 Clinical trial environment9.6 Regulatory environment in Malaysia9.7 Evolution of Malaysian GCP9.8 CRO market in Malaysia9.9 Clinical trials in Malaysia9.10 Registration of clinical trials9.11 Challenges and future outlookChapter 10: Clinical research in Hong KongAbstract:10.1 Background and history10.2 Pharmaceutical industry in Hong Kong10.3 Healthcare system in Hong Kong10.4 Clinical trials in Hong Kong10.5 The regulatory environment10.6 Clinical trials in Hong Kong10.7 Environmental analysis10.8 Future outlookChapter 11: Clinical research in the Philippines, Indonesia VietnamAbstract:11.1 Clinical research in the Philippines11.2 Clinical research in Indonesia11.3 Clinical research in VietnamChapter 12: ConclusionsAbstract:12.1 PESTLE analysis12.2 Political environment12.3 Economic environment12.4 Socio-cultural forces12.5 Technological factors12.6 Legal environment12.7 Other environmental factors12.8 Strategic issues for the CRO industry12.9 Future outlookBibliographyIndex
