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.
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 prevalJ2ence 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
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