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Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment
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Emerging Clinical Trial Locations
Market dynamics and the changing healthcare and regulatory environment
Report Overview
Pharma and biotech companies are attempting to combat escalating R&D cost.....
Emerging Clinical Trial Locations Market dynamics and the changing healthcare and regulatory environment Report Overview Pharma and biotech companies are attempting to combat escalating R&D costs and lengthy clinical trial timelines by improving patient recruitment and the efficiency of clinical trial analysis/reporting. The biopharmaceutical market has recognized the opportunities and advantages that exist by conducting clinical trials in emerging markets. Although these markets offer a number of significant benefits over traditional clinical trial settings, there remain a variety of challenges and problems associated with conducting trials in emerging regions. ‘Emerging Clinical Trial Locations’ is a report published by Business Insights that provides a comprehensive examination of the clinical trial landscape in emerging countries, with specific focus on China, India, Central and Eastern Europe and Latin America. It identifies the major drivers and barriers to conducting clincial trials in emerging regions and profiles key issues for consideration when selecting a trial site. For each featured region, this report provides an assessment of pharma market dynamics, the heathcare system and CRO-related infrastructure, leading CROs established within the region and the regulatory and legislative frameworks that govern the conduct of clinical trials. Key Findings Russia is one of the world leaders in patient enrolment - the average patient recruitment rate in 2006 exceeded 4.7 patients per site per month. For some nosologies, this figure is 10 times higher than in Western Europe and the US. The Chinese Clinical Trial Register (CHiCTR) and The Clinical Trials Registry in India (CTRI) have helped to encourage all clinical trials in these regions to be registered before the enrolment of the first participant, and to disclose the mandatory 20 items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. By the end of May 2009, 895 clinical trials were registered in India. By comparison in 2006, 150 clinical trials had been approved by the Drug Controller of India (DCI). India is able to offer significant cost savings compared with conducting clinical trials in western countries. Phase I trials are approximately 50% cheaper than western equivalents, while Phase II and Phase III are 60% less expensive. The Chinese CRO market was valued at $250m in 2008. The market is expected to grow at a CAGR of 33% over the next four years to reach $791m in 2012. By that time, Chinese CROs will account for an estimated 2.3% of the global CRO market. China’s IP protections systems still have a number of serious flaws, despite attempts to conform with international IP protection standards through amendments of the Patent Law and restriction of product approvals by the SFDA. The number of clinical trials in Brazil has increased from 9 in 2000, to 1177 by 2008. In Argentina the number of trials has risen from 6 to 801 over the same period, while Mexico has witnessed an increase from 63 to 2014. The costs of conducting clinical trials in Latin America vary from substantially less expensive than the US to slightly more expensive. In recent trials, the cost per patient for Latin America has varied from savings of 50% to relative cost increases against US per patient costs. The value of the Polish clinical trial market for Phase I to Phase IV clinical trials and bioequivalence studies has been estimated to be worth K167m ($224m) in 2008, having increased in value by 10% from the Use this report to... Assess the viability of key emerging clinical trial locations including China, India, Eastern Europe and Latin America by analyzing each region based on: • Pharma market dynamics • Drivers of CRO market growth • Barriers to CRO market growth • Healthcare systems and hospital resources • Related regulation and legislation Examine the phases of the clinical trial process with analysis of clinical trial protocols, related ethical issues, clinical trial study design and planning, patient identification and recruitment, and the influence of regulatory authorities and agencies. Understand how new technology platforms are enhancing clincial trial effectiveness and identify the issues and challenges associated with these innovations. Analyze the major market drivers and barriers for clinical trials in emerging markets with analysis of the key benefits and challenges associated with trial sites in emerging countries and the key considerations for site selection. Report Highlights [Studien Infos ausblenden] |
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Table of Contents Emerging clinical trial locations - Executive summary 16 Introduction 16 Conducting clinical trials in emerging markets 17 India 18 China 19 Latin America 20 Central and Eastern Europe 21 Chapter 1 Introduction 24 Summary 24 Introduction 25 Generic competition 25 Intellectual property protection 25 Managing regulatory compliance 27 Cost containment and government funding restrictions 28 Obtaining and maintaining competitive advantage 28 Recruitment and retention of a skilled workforce 29 Improvement to R&D productivity 30 High risks and costs associated with drug development 30 Escalating costs of clinical trials 30 Global increase in the number of clinical trials conducted 34 Longer R&D timelines 34 Increased attrition rates during R&D 37 Clinical trial study design and planning 38 Clinical trial study design 38 Clinical trial study protocol 38 Clinical trial sponsors 38 Identifying and recruiting patients 39 Role of CROs 39 Information technology and new technology platforms 40 Drivers of development 40 Advantages associated with EDC 40 Advantages of electronic Clinical Trial Management Systems (CTMS) 41 Cost saving 42 Issues and challenges 42 Electronic records and signatures 42 Integration and linkage of electronic systems 43 Security and confidentiality of patient data 43 Chapter 2 Conducting clinical trials in emerging markets 46 Summary 46 Introduction 47 Market drivers 49 Rapid recruitment of patients and clinical trial investigators 49 Significant cost benefits 51 Improving transparency and efficiency of regulatory systems 52 Harmonization and standardization of regulatory requirements 53 Expansion of CROs 54 Conducive hospital infrastructure and healthcare systems 56 Enhanced clinical site effectiveness 57 Future commercial value 58 Key barriers 59 Concerns over the clinical trial transparency 60 Publication bias 61 Selective reporting 62 Duplicate publication 62 Conflict of interest 62 Availability of demographic and epidemiology data 62 Critical components concerning capacity building 63 Assimilation of individual national regulations and guidelines 66 United States 66 Japan 67 European Union 68 Language translation 69 Ethical challenges 69 Health needs of the population under study 70 Respect for potential and enrolled subjects 70 Ethical oversight 71 Lack of review by institutional review board (IRB) 71 Absence of informed consent 72 Scientific validity 73 Inadequate protection of intellectual property 73 Clinical trial logistics 74 Import licenses and applications 74 Customs regulations 75 Storage, handling and distribution 75 Selecting an appropriate CRO 76 Patient enrolment 79 Site selection 80 Site activation 80 Patient recruitment 80 Chapter 3 India 84 Summary 84 Introduction 85 Geographic 85 Political 85 Economic 85 Market dynamics 85 Vital statistics 85 Population statistics 87 Epidemiology and prevalence of major disease 88 Pharmaceutical market 89 Biotechnology market 92 CRO market 94 Clinical trial market 97 Geographic focus of the Indian clinical research industry 97 Market drivers 100 Population ethnicity and genetic diversity 100 Large complement of trained medical specialists in India 101 Significant cost savings 102 Government incentives 103 Creation of the Clinical Trials Registry – India (CTRI) 103 Sophisticated logistics and clinical research infrastructure 104 Comprehensive IT and IT enabled support (ITES) base 105 Key barriers 106 Ethical issues 106 Lack of experienced investigators 107 Inability to detect and monitor ADRs 107 Bribery and corruption 107 Healthcare 108 Healthcare system 108 National level 108 State level 108 Regional level 108 District level 109 Sub-divisional/Taluka level 110 Community level 110 Primary health centre (PHC) level 110 Sub health centre (SHC) level 110 Hospital resources 110 Regulation and legislation 112 Regulatory authorities 112 The Ministry of Health and Family Welfare 112 Central Drug Standard Control Organization (CDSCO) 115 Drug Controller General of India (DCGI) 115 Indian Council of Medical Research (ICMR) 116 Clinical trial regulation 116 Harmonization of the clinical trial approval process 118 Legislation 120 Patent law and WTO TRIPS 120 Schedule Y Drugs and Cosmetics Act and Rule 122 Summary of the recent regulatory and legislative changes 123 Evolution of the regulatory environment 124 Expected improved collaboration: DCGI with international agencies 125 Anticipation of approval for early phase studies in India 126 Registration and regulation of CROs in India 126 Future reform and emphasis on improved pharmacovigilance in India 127 India to implement an electronic management system 128 Outlook 129 Chapter 4 China 132 Summary 132 Introduction 133 Geographic 133 Political 133 Economic 134 Market dynamics 136 Vital statistics 136 Population statistics 136 Epidemiology and prevalence of major disease 136 Pharmaceutical market 138 CRO market 140 Overseas CROs 142 Joint venture companies 143 Local CROs 144 Clinical trial market 146 Market drivers 147 Rapid patient recruitment from large pool of treatment naïve patients 147 Well-trained and motivated clinical trial investigators 147 Major cost savings 147 Increasing importance of the pharmaceutical market in China 148 US government opens FDA offices in China 149 Financial support and incentives from the Chinese government 149 Creation of the Chinese Clinical Trial Register (CHiCTR) 150 Key barriers 152 Cultural and linguistic 152 Delays to application and gaining approval 152 Due diligence required to ensure intellectual property protection 152 Issues over importation and importation licenses 153 Monitor compliance of SFDA GCP with ICH GCP 153 Healthcare 154 Healthcare system 154 Overview 154 Healthcare reforms 156 Healthcare institutions 157 Hospital resources 158 Regulation 160 Regulatory authorities 160 State Food and Drug Administration (SFDA) 160 Department of drug registration 161 Clinical trial regulation 161 Application and approval of the new drug clinical trial study 162 Registration approval for the manufacture of the new drug for market 163 Legislation 165 Patent Law and WTO TRIPS 165 Drug Administration Law of the People's Republic of China 168 Outlook 172 Chapter 5 Latin America 174 Summary 174 Introduction 175 Geographic 175 Brazil 175 Argentina 175 Mexico 176 Political 176 Brazil 176 Argentina 176 Mexico 177 Economic 177 Brazil 177 Argentina 177 Mexico 177 Market dynamics 178 Vital statistics - Brazil 178 Population statistics 178 Epidemiology and prevalence of major disease 178 Vital statistics - Argentina 179 Population statistics 179 Epidemiology and prevalence of major diseases 179 Vital statistics - Mexico 180 Population statistics 180 Epidemiology and prevalence of major disease 180 Pharmaceutical market 182 CRO market 185 Clinical trial market 186 Market drivers 188 Significant cost savings 188 High concentration of population in urban centers 188 High ethnic diversity 189 High patient enrolment, compliance and retention rates 189 A major growing Latin American pharmaceutical market 190 Reverse seasons advantages 190 Commonality of Spanish language 190 Accessibility to medical professionals and clinical trial investigators 190 National clinical trials register – Argentina 191 Key barriers 191 Concerns over intellectual property protection 191 Inconsistent regulatory environment 192 Cultural challenges and issues 193 Healthcare 194 Healthcare system- Brazil 194 Hospital resources - Brazil 194 Healthcare system - Argentina 195 Hospital resources - Argentina 195 Healthcare system - Mexico 196 Hospital resources - Mexico 197 Regulation and guidelines 198 Regulatory authorities 198 The Pan American Network for Drug Regulatory Harmonization (PANDRH) 198 ANVISA - Brazil 198 Brazilian Research Ethics Commission (CONEP) 199 ANMAT - Argentina 201 SSA - Mexico 202 COFEPRIS - Mexico 202 Clinical trial regulation 203 Brazil 204 Argentina 206 Mexico 208 Guidelines 209 Good Clinical Practices: Document of the Americas 209 The Buenos Aires Declaration on Ethics and Clinical Trials 212 Import licenses for drugs in clinical trials - Mexico 215 Outlook 216 Chapter 6 Central and Eastern Europe 218 Summary 218 Introduction 219 Geographic 219 Czech Republic 220 Poland 220 Russian Federation 220 Political 220 Czech Republic 220 Poland 221 Russian Federation 221 Economic 221 Czech Republic 221 Poland 221 Russian Federation 222 Market dynamics 223 Vital statistics 223 Population statistics 223 Epidemiology and prevalence of major diseases 225 Pharmaceutical market 228 CRO market 230 Czech Republic 230 Poland 230 Russian Federation 231 Clinical trial market 233 Czech Republic 235 Poland 235 Russian Federation 236 Market drivers 238 Large eligible treatment naïve population who exhibit high retention rates 238 Large pool of dedicated, well trained and motivated investigators 239 Cost savings 239 Centralized healthcare systems and well-developed referral systems 240 Entry of Russian Federation into the World Trade Organization (WTO) 240 Positive assessments by the US FDA (Poland) 241 Key barriers 241 Poor hospital infrastructure with inadequate medical equipment 241 Cultural differences and issues 242 Potential delays importing the study drug (Russia) 242 Concerns and issues obtained from regulatory inspections by the FDA (Russia) 243 Lack of clinical trial experience amongst hospital staff and hospital services 244 Healthcare 245 Healthcare system – Czech Republic 245 Hospital resources – Czech Republic 246 Healthcare system – Poland 246 Ministry of Health 247 National health fund 247 Territorial self-government administrations 247 Hospital resources – Poland 247 Healthcare system – Russian Federation 248 Hospital resources – Russian Federation 249 Regulation and legislation 250 Regulatory authorities 250 SUKL – Czech Republic 250 NIL – Poland 251 RZN – Russian Federation 252 Clinical trial regulation 253 Czech Republic 254 Poland 258 Russian Federation 258 Legislation 261 Poland removes tax block for clinical trials 261 Decree no. 226/2008 on good clinical practices - Czech Republic 261 Russia 261 Outlook 262 Appendix 264 Introduction to clinical trials 264 Clinical trial phases 264 Phase I 264 Phase II 264 Phase III 264 Phase IV 265 What is a clinical trial 265 Clinical trials of pharmaceutical agents 265 Types of clinical trial 266 Pilot studies 266 Proof of concept (PoC) trials 266 Randomized clinical studies 267 Controlled clinical trials 267 Parallel studies 267 Parallel group trials 267 Cohort studies 268 Case control studies 268 Role of the chief investigator 268 Clinical trial protocol and procedure 269 Determination of the clinical trial size 269 Role of the coordinating centre and trials unit 270 Role of the trial coordinator 270 The trial principle investigator 270 Forms and data management 270 Trial data analysis and evaluation 271 Ethical issues and conduct of clinical trial research 271 Interpretation and publication of clinical trial results 272 Principle regulatory agencies 272 The European Agency for the Evaluation of Medicinal Products (EMEA) 272 The United States Food and Drug Administration (US FDA) 273 Japanese Ministry of Health, Labor and Welfare (MHLW) 273 Methodology statement 274 Primary Data and Information Gathering 274 Secondary data and information gathering 275 Definitions of Product-Life Cycle stages 277 Glossary of abbreviations and acronyms 277 Index 284 [Inhaltsverzeichnis ausblenden] |
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List of Tables Table 2.1: Demographics of selected emerging markets, 2007 50 Table 2.2: Ethical principles & their application for research 72 Table 3.3: Statistical healthcare data India 88 Table 3.4: Ten leading causes of death (%) in India, 2002 88 Table 3.5: Diseases of the developed world in India 89 Table 3.6: Top 10 pharmaceutical companies ($m) in India, 2008 92 Table 3.7: Major biotechnology products in India and their companies 93 Table 3.8: Major CROs operating in India 95 Table 3.9: Major specialty hospital groups operating in Northern India 98 Table 3.10: Regulatory authorities based in Northern India 99 Table 3.11: Snapshot of hospitals in India 111 Table 4.12: China Population Projections (m people), 1950-2050 137 Table 4.13: Ten leading causes of death in China, 2002 137 Table 4.14: Prevalence of major cancers in China, 2007 138 Table 4.15: Top 10 pharmaceutical companies ($m) in China, 2008 140 Table 4.16: Major multinational CROs operating in China 142 Table 4.17: Local Chinese owned CROs 145 Table 4.18: Number of healthcare institutions according to ownership China 158 Table 4.19: Total number of hospitals by ranking China 159 Table 4.20: Chinese government agencies responsible for drug regulation 160 Table 5.21: Ten leading causes of death, Argentina, 2003 180 Table 5.22: Ten leading causes of death, Mexico, 2004 (compared to rate in 2000) 181 Table 5.23: Top 10 pharma companies ($m) in Brazil, Argentina, and Mexico, 2008 184 Table 5.24: Major CROs operating in Latin America, 2009 185 Table 5.25: Ten leading causes of death in Brazil, 2003 195 Table 5.26: Snapshot of hospitals in Argentina, 2007 196 Table 6.27: Central and Eastern Europe population projection (m people), 2009 223 Table 6.28: Population statistics - Russia 224 Table 6.29: Principle city population statistics – Russia, 2008 225 Table 6.30: Estimated total deaths (thousands) by cause and by selected country 227 Table 6.31: Top 10 pharmaceutical companies ($m) in Russia, Poland and the Czech Republic, 2008 229 Table 6.32: Major CROs operating in Eastern Europe (including Poland and Czech Republic), 2009 231 Table 6.33: Top 10 Russian regions by no. of new investigative sites, 2006-2008 237 Table 6.34: Snapshot of hospitals in the Czech Republic 246 Table 6.35: Snapshot of hospitals in Poland 248 Table 6.36: Contact details regulatory authorities in selected Central and Eastern European countries 251 Table 6.37: Fees for clinical trial application (€) in the Czech Republic, April 2009 255 Table 6.38: Guidelines and Forms for Clinical Trials Czech Republic 256 Table 6.39: Checklist of documents for initial application in Czech Republic 257 List of Figures Figure 1.1: Key issues facing Pharma and Biotech companies 26 Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008 31 Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e 32 Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e 33 Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e 33 Figure 2.6: Comparison of locations across selected countries 48 Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process 53 Figure 2.8: CRO Segment Leaders 55 Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries 58 Figure 2.10: Fewer ineffective sites in the emerging countries 58 Figure 2.11: Critical components for capacity building/conducting clinical trials 64 Figure 2.12: Assessing clinical trial location feasibility 65 Figure 2.13: CRO selection criteria 79 Figure 3.14: GDP in India (%) by sector 86 Figure 3.15: Projected growth of healthcare industry in India ($bn), 2008-2022 86 Figure 3.16: Population projection (millions) in India, 2000-2020 87 Figure 3.17: Pharma industry in India ($bn), 2007-2010 90 Figure 3.18: Market share (%) between MNCs and local pharmaceutical companies in India, 2003- 2007 91 Figure 3.19: Outsourced clinical trial market in India (US$), 2002-2010 96 Figure 3.20: Clinical trials in India (by phase), 2009 97 Figure 3.21: Types of disease and types of hospitals in India 100 Figure 3.22: Cost of clinical trials (%) in India vs US 103 Figure 3.23: Structure of healthcare system in India 109 Figure 3.24: Current organogram of the Ministry of Health and Family Welfare 113 Figure 3.25: Proposed organogram of the Ministry of Health and Family Welfare 114 Figure 3.26: Approval categories of global clinical trials in India 119 Figure 4.27: Administrative divisions of the People’s Republic of China 135 Figure 4.28: Pharma market in China ($), 2007-2008 139 Figure 4.29: CRO market in China (US$), 2007-2012 141 Figure 4.30: Cost of clinical trials (%) in China vs western countries 148 Figure 4.31: The Chinese Healthcare System 155 Figure 4.32: NRCMCS medical cover cost and benefits in China 157 Figure 4.33: Current drug approval and evaluation process in China 163 Figure 4.34: Application and approval procedure for clinical trials China 165 Figure 4.35: Location of accredited sites for clinical trials in China 171 Figure 5.36: Population projection (‘000s) – Brazil, 2000-2050 178 Figure 5.37: Population projection (thousands) – Argentina, 2000-2050 179 Figure 5.38: Population projection (thousands) – Mexico, 2000-2050 181 Figure 5.39: Forecast growth ($bn) Latin America pharmaceutical market, 2008-2013 182 Figure 5.40: Latin America pharmaceutical market 2008 183 Figure 5.41: No. of clinical trials in Latin America, 2000-2008 186 Figure 5.42: Clinical trials by phase in Latin America (number of trials), 2008 187 Figure 5.43: Registered Research Ethics Committees (REC) by Region – Brazil 2008 201 Figure 5.44: Regulation of clinical trials in Latin America 2007 203 Figure 5.45: Regulatory flowchart - Brazil 205 Figure 5.46: Regulatory flowchart - Argentina 207 Figure 5.47: Regulatory flowchart - Mexico 209 Figure 6.48: Pharmaceutical market by selected Central and Eastern European countries, 2007 228 Figure 6.49: Clinical trials Europe 234 Figure 6.50: Clinical trials by phase (no trials) in the Czech Republic, 2008 235 Figure 6.51: Clinical trials market ($m) in Poland, 2007-2010 236 Figure 6.52: Clinical trials by therapy area (%) in Russia, 2008 237 Figure 6.53: Clinical trials by phase (%) in Russia, 2008 238 Figure 6.54: FDA inspection deficiencies in Russian sites 244 [Tabellenverzeichnis ausblenden] |
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