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
Published on June 2009

Report Summary

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.

Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 1/13


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.

Table of Content

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
CRO market 140
Overseas CROs 142
Joint venture companies 143
Local CROs 144
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
State Food and Drug Administration (SFDA) 160
Department of drug registration 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
Vital statistics - Argentina 179
Epidemiology and prevalence of major diseases 179
Vital statistics - Mexico 180
CRO market 185
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
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
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
Economic 221



Czech Republic 221
Poland 221
Market dynamics 223
Vital statistics 223
Epidemiology and prevalence of major diseases 225
CRO market 230
Czech Republic 230
Poland 230
Czech Republic 235
Poland 235
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
SUKL ' Czech Republic 250
NIL ' Poland 251
RZN ' Russian Federation 252
Czech Republic 254
Poland 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
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
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



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