Sahoo Clinical Research in Asia

Opportunities and Challenges
1. Auflage 2012
ISBN: 978-1-908818-13-3
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 412 Seiten

Reihe: Woodhead Publishing Series in Biomedicine

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

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.

Autoren/Hrsg.

Sahoo, U.

Leseproben

List of figures and table
Figures
1.1. Drug development life-cycle 2 1.2. The growing contract research market 7 1.3. Overall country attractiveness index 13 1.4. Country segmentation 15 1.5. Number of clinical trials in the Asia region 18 1.6. Number of industry-sponsored trials in the Asia region 18 2.1. Global pharmaceutical industry – an overview 28 2.2. Projections of total public health and long-term care expenditure (% GDP) 29 2.3. Japanese CRO industry revenue and staff numbers 30 2.4. Clinical development revenue by phase in Japan (2010) 31 2.5. Local and global CROs in Japan 32 2.6. Evolution of PMDA 34 2.7. Consultation and review system for drugs and devices 37 2.8. Global clinical trial consultations 37 2.9. Evolution of GCP in Japan 38 2.10. Global clinical trials in Japan 47 2.11. Model 1: global pharma with global CRO 48 2.12. Model 2: global pharma with global CRO and its allied local CRO 49 2.13. Model 3: global pharma’s local affiliate and CRO 50 2.14. Model 4: in-country clinical caretaker 50 2.15. Tripartite cooperations to study ethnic factors 52 3.1. India’s share of abbreviated new drug approvals granted in the USA (2008) 56 3.2. Percentage of drug master filings in the USA (2008), by country 57 3.3. Leading service providers in clinical research business 63 3.4. Process flow-chart for BABE trials 65 3.5. Growth of clinical trials in India 68 3.6. Clinical trials in India, by phase 69 3.7. Healthcare resources in India: (a) absolute numbers, 2009; (b) average population served by one professional 93 3.8. Health Investment outlays, 1992–2012 94 4.1. Pharmaceutical market size: world vs China – in 2010 and 2015 108 4.2. Government of China’s spending on education, healthcare and social security (% GDP) 112 4.3. Population of China by age group (%), 1964, 2000, 2035 115 4.4. China’s urban population (%), 1970, 2000, 2030 115 4.5. China’s CRO market 123 4.6. Clinical research players in China 125 4.7. Growth of industry-sponsored clinical trials in China 126 4.8. Clinical trials in China, by phase 126 4.9. Number of SFDA accredited study sites in China 129 4.10. Review and approval process for Drug Clinical Trial Approval 145 5.1. New chemical entities in the LG Life Sciences pipeline 154 5.2. The IND review process in South Korea 157 5.3. Growth of industry-sponsored clinical trials in South Korea 163 5.4. Industry-sponsored clinical trials in South Korea, by phase 163 6.1. IND review process in Taiwan 183 6.2. IND review process 184 6.3. Bridging study – current evaluation process 185 6.4. Online application consultation process flow 186 6.5. Regulatory approval process in Taiwan 188 6.6. Study start-up timelines in Taiwan 189 6.7. Growth of industry-sponsored clinical trials in Taiwan 191 6.8. Industry-sponsored clinical trials in Taiwan, by phase 191 7.1. Clinical trials in Singapore by therapeutic area 210 7.2. Clinical research players in Singapore 211 7.3. Growth of clinical trials in Singapore 212 7.4. Clinical trials in Singapore, by phase 212 8.1. Study start-up timelines in Thailand 258 8.2. Growth of clinical trials in Thailand 262 8.3. Industry-sponsored clinical trials in Thailand, by phase 262 9.1. Safety reporting process for drugs in clinical trial in Malaysia 282 9.2. Growth of clinical trials in Malaysia 287 9.3. Industry-sponsored clinical trials in Malaysia, by phase 288 9.4. Malaysia value proposition 289 10.1. Hong Kong’s healthcare system 297 10.2. Overall structure of the healthcare system in Hong Kong 298 10.3. Flow chart for ethics committee and regulatory submissions 307 10.4. Study start-up timelines in Hong Kong 307 10.5. Growth of clinical trials in Hong Kong 310 10.6. Clinical trials in Hong Kong, by phase 310 11.1. Growth of clinical trials in the Philippines 319 11.2. Clinical trials in the Philippines, by phase 320 11.3. Growth of clinical trials in Indonesia 325 11.4. Clinical trials in Indonesia, by phase 325 11.5. Growth of clinical trials in Vietnam 333 11.6. Clinical trials in Vietnam, by phase 333 Tables
1.1. Global pharmaceutical market analysis 3 1.2. Pharmaceutical market size in select Asian countries 3 1.3. Health expenditure in select Asian countries 4 1.4. Top 15 global pharmaceutical players and their clinical research, 2009 5 1.5. Developed vs emerging Asian pharmaceutical markets 6 1.6. Global CROs and their financials 8 1.7. CRO services mix 9 1.8. Big pharma R&D investment in Asia 10 1.9. Global CRO offerings in Asia 14 1.10. Key economic indicators in Asia-Pacific 17 1.11. Number of industry-sponsored clinical trials in Asia by phase 19 1.12. US FDA inspections in Asia 20 1.13. Deficiency codes 21 2.1. Japanese pharma companies’ industry-sponsored trials in Asia (December 2009) 31 2.2. Regulatory requirements for IRB and PMDA 43 3.1. Pharma partnerships in India 58 3.2. Global pharma R&D and outsourcing by 2010 58 3.3. Drug development pipeline of key Indian companies 59 3.4. US FDA approved new drugs – data generated from India 62 3.5. Pharma companies undertaking trials in India 69 3.6. Research institutes in India 90 3.7. Healthcare infrastructure in India (March 2008) 91 3.8. Healthcare education infrastructure in India, 2009–10 92 3.9. Health expenditure in India 95 3.10. A comparison of drug prices, USA vs India 95 3.11. Languages in India 98 3.12. Technology-driven service providers in India 100 4.1. Investments by major multinational pharma companies in...