Emerging Clinical Trial Locations –Latin America: Market dynamics and the changing healthcare and regulatory environment

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets. Major issues confronting both the pharmaceutical and biotechnology market are: the requirement to reduce the escalating costs and risks associated with drug development; and reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. The biopharmaceutical industry has recognized the opportunities and advantages that exist by conducting clinical trials in what are referred to as the emerging markets. This report identifies market dynamics and key regulatory changes, and analyzes the implications and factors which need to be taken into consideration when conducting clinical trials in Latin America.

Report Highlights

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Table of Contents
Emerging clinical trial locations - Latin America
Executive summary 10
Introduction 10
Conducting clinical trials in emerging markets 11
Latin America 12
Chapter 1 Introduction 14
Summary 14
Introduction 15
Generic competition 15
Intellectual property protection 15
Managing regulatory compliance 17
Cost containment and government funding restrictions 18
Obtaining and maintaining competitive advantage 18
Recruitment and retention of a skilled workforce 19
Improvement to R&D productivity 20
High risks and costs associated with drug development 20
Escalating costs of clinical trials 20
Global increase in the number of clinical trials conducted 23
Longer R&D timelines 24
Increased attrition rates during R&D 26
Clinical trial study design and planning 27
Clinical trial study design 27
Clinical trial study protocol 28
Clinical trial sponsors 28
Identifying and recruiting patients 28
Role of CROs 29
Information technology and new technology platforms 29
Drivers of development 30
Advantages associated with EDC 30
Advantages of electronic Clinical Trial Management Systems
(CTMS) 30
Cost saving 31
Issues and challenges 31
Electronic records and signatures 31
Integration and linkage of electronic systems 32
Security and confidentiality of patient data 32
Chapter 2 Conducting clinical trials in emerging markets 36
Summary 36
Introduction 37
Market drivers 39
Rapid recruitment of patients and clinical trial investigators 39
Significant cost benefits 41
Improving transparency and efficiency of regulatory systems 42
Harmonization and standardization of regulatory requirements 43
Expansion of CROs 44
Conducive hospital infrastructure and healthcare systems 46
Enhanced clinical site effectiveness 47
Future commercial value 49
Key barriers 50
Concerns over the clinical trial transparency 50
Publication bias 51
Selective reporting 52
Duplicate publication 53
Conflict of interest 53
Availability of demographic and epidemiology data 53
Critical components concerning capacity building 53
Assimilation of individual national regulations and guidelines 56
United States 56
Japan 57
European Union 58
Language translation 59
Ethical challenges 60
Health needs of the population under study 60
Respect for potential and enrolled subjects 61
Ethical oversight 61
Lack of review by institutional review board (IRB) 61
Absence of informed consent 62
Scientific validity 63
Inadequate protection of intellectual property 64
Clinical trial logistics 64
Import licenses and applications 64
Customs regulations 65
Storage, handling and distribution 66
Selecting an appropriate CRO 67
Patient enrolment 70
Site selection 70
Site activation 71
Patient recruitment 71
Chapter 3 Latin America 74
Summary 74
Introduction 75
Geographic 75
Brazil 75
Argentina 75
Mexico 76
Political 76
Brazil 76
Argentina 76
Mexico 77
Economic 77
Brazil 77
Argentina 77
Mexico 77
Market dynamics 78
Vital statistics - Brazil 78
Population statistics 78
Epidemiology and prevalence of major disease 78
Vital statistics - Argentina 79
Population statistics 79
Epidemiology and prevalence of major diseases 79
Vital statistics - Mexico 80
Population statistics 80
Epidemiology and prevalence of major disease 80
Pharmaceutical market 82
CRO market 85
Clinical trial market 86
Market drivers 88
Significant cost savings 88
High concentration of population in urban centers 88
High ethnic diversity 89
High patient enrolment, compliance and retention rates 89
A major growing Latin American pharmaceutical market 90
Reverse seasons advantages 90
Commonality of Spanish language 90
Accessibility to medical professionals and clinical trial investigators 90
National clinical trials register – Argentina 91
Key barriers 92
Concerns over intellectual property protection 92
Inconsistent regulatory environment 93
Cultural challenges and issues 93
Healthcare 95
Healthcare system- Brazil 95
Hospital resources - Brazil 95
Healthcare system - Argentina 96
Hospital resources - Argentina 96
Healthcare system - Mexico 97
Hospital resources - Mexico 98
Regulation and guidelines 99
Regulatory authorities 99
The Pan American Network for Drug Regulatory Harmonization
(PANDRH) 99
ANVISA - Brazil 99
Brazilian Research Ethics Commission (CONEP) 100
ANMAT - Argentina 102
SSA - Mexico 103
COFEPRIS - Mexico 103
Clinical trial regulation 104
Brazil 105
Argentina 107
Mexico 109
Guidelines 111
Good Clinical Practices: Document of the Americas 111
The Buenos Aires Declaration on Ethics and Clinical Trials 114
Import licenses for drugs in clinical trials - Mexico 117
Outlook 118
Chapter 4 Appendix 120
Introduction to clinical trials 120
Clinical trial phases 120
Phase I 120
Phase II 120
Phase III 121
Phase IV 121
What is a clinical trial 121
Clinical trials of pharmaceutical agents 122
Types of clinical trial 123
Pilot studies 123
Proof of concept (PoC) trials 123
Randomized clinical studies 123
Controlled clinical trials 123
Parallel studies 124
Parallel group trials 124
Cohort studies 124
Case control studies 124
Role of the chief investigator 125
Clinical trial protocol and procedure 125
Determination of the clinical trial size 126
Role of the coordinating centre and trials unit 126
Role of the trial coordinator 126
The trial principle investigator 127
Forms and data management 127
Trial data analysis and evaluation 128
Ethical issues and conduct of clinical trial research 128
Interpretation and publication of clinical trial results 129
Principle regulatory agencies 129
The European Agency for the Evaluation of Medicinal Products (EMEA) 129
The United States Food and Drug Administration (US FDA) 129
Japanese Ministry of Health, Labor and Welfare (MHLW) 130
Methodology statement 131
Primary Data and Information Gathering 131
Secondary data and information gathering 132
Definitions of Product-Life Cycle stages 134
Glossary of abbreviations and acronyms 135
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List of Tables
Table 2.1: Demographics of selected emerging markets, 2007 40
Table 2.2: Ethical principles & their application for research 62
Table 3.3: Ten leading causes of death, Argentina, 2003 80
Table 3.4: Ten leading causes of death, Mexico, 2004 (compared to rate in 2000) 81
Table 3.5: Top 10 pharma companies ($m) in Brazil, Argentina, and Mexico, 2008 84
Table 3.6: Major CROs operating in Latin America, 2009 85
Table 3.7: Ten leading causes of death in Brazil, 2003 96
Table 3.8: Snapshot of hospitals in Argentina, 2007 97
List of Figures
Figure 1.1: Key issues facing Pharma and Biotech companies 16
Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008 21
Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e 22
Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e 22
Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e 23
Figure 2.6: Comparison of locations across selected countries 38
Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process 43
Figure 2.8: CRO Segment Leaders 45
Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries 48
Figure 2.10: Fewer ineffective sites in the emerging countries 48
Figure 2.11: Critical components for capacity building/conducting clinical trials 54
Figure 2.12: Assessing clinical trial location feasibility 55
Figure 2.13: CRO selection criteria 70
Figure 3.14: Population projection (‘000s) – Brazil, 2000-2050 78
Figure 3.15: Population projection (thousands) – Argentina, 2000-2050 79
Figure 3.16: Population projection (thousands) – Mexico, 2000-2050 81
Figure 3.17: Forecast growth ($bn) Latin America pharmaceutical market, 2008-2013 82
Figure 3.18: Latin America pharmaceutical market 2008 83
Figure 3.19: No. of clinical trials in Latin America, 2000-2008 86
Figure 3.20: Clinical trials by phase in Latin America (number of trials), 2008 87
Figure 3.21: Registered Research Ethics Committees (REC) by Region – Brazil 2008 102
Figure 3.22: Regulation of clinical trials in Latin America 2007 104
Figure 3.23: Regulatory flowchart - Brazil 106
Figure 3.24: Regulatory flowchart - Argentina 108
Figure 3.25: Regulatory flowchart - Mexico 110
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