NEW YORK, Dec. 1 Reportlinker.com announces that a new market research report is available in its catalogue:
Emerging Clinical Trial Locations - Eastern Europe: Market dynamics and the changing healthcare and regulatory environment
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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 Eastern Europe.
Table of Contents
Emerging clinical trial locations - Eastern Europe
Executive summary 10
Introduction 10
Conducting clinical trials in emerging markets 11
Central and Eastern Europe 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 Central and Eastern Europe 74
Summary 74
Introduction 75
Geographic 75
Czech Republic 76
Poland 76
Russian Federation 76
Political 76
Czech Republic 76
Poland 77
Russian Federation 77
Economic 77
Czech Republic 77
Poland 78
Russian Federation 78
Market dynamics 79
Vital statistics 79
Population statistics 79
Epidemiology and prevalence of major diseases 81
Pharmaceutical market 84
CRO market 86
Czech Republic 86
Poland 86
Russian Federation 87
Clinical trial market 89
Czech Republic 91
Poland 91
Russian Federation 92
Market drivers 95
Large eligible treatment naive population who exhibit high retention rates 95
Large pool of dedicated, well trained and motivated investigators 95
Cost savings 96
Centralized healthcare systems and well-developed referral systems 97
Entry of Russian Federation into the World Trade Organization (WTO) 97
Positive assessments by the US FDA (Poland) 98
Key barriers 98
Poor hospital infrastructure with inadequate medical equipment 98
Cultural differences and issues 99
Potential delays importing the study drug (Russia) 99
Concerns and issues obtained from regulatory inspections by the FDA
(Russia) 100
Lack of clinical trial experience amongst hospital staff and hospital services 102
Healthcare 102
Healthcare system - Czech Republic 102
Hospital resources - Czech Republic 103
Healthcare system - Poland 104
Ministry of Health 104
National health fund 104
Territorial self-government administrations 104
Hospital resources - Poland 105
Healthcare system - Russian Federation 105
Hospital resources - Russian Federation 106
Regulation and legislation 108
Regulatory authorities 108
SUKL - Czech Republic 108
NIL - Poland 109
RZN - Russian Federation 110
Clinical trial regulation 111
Czech Republic 112
Poland 116
Russian Federation 116
Legislation 119
Poland removes tax block for clinical trials 119
Decree no. 226/2008 on good clinical practices - Czech Republic 119
Russia 119
Outlook 120
Chapter 4 Appendix 122
Introduction to clinical trials 122
Clinical trial phases 122
Phase I 122
Phase II 122
Phase III 123
Phase IV 123
What is a clinical trial 123
Clinical trials of pharmaceutical agents 124
Types of clinical trial 125
Pilot studies 125
Proof of concept (PoC) trials 125
Randomized clinical studies 125
Controlled clinical trials 125
Parallel studies 126
Parallel group trials 126
Cohort studies 126
Case control studies 126
Role of the chief investigator 127
Clinical trial protocol and procedure 127
Determination of the clinical trial size 128
Role of the coordinating centre and trials unit 128
Role of the trial coordinator 128
The trial principle investigator 129
Forms and data management 129
Trial data analysis and evaluation 130
Ethical issues and conduct of clinical trial research 130
Interpretation and publication of clinical trial results 131
Principle regulatory agencies 131
The European Agency for the Evaluation of Medicinal Products (EMEA) 131
The United States Food and Drug Administration (US FDA) 131
Japanese Ministry of Health, Labor and Welfare (MHLW) 132
Methodology statement 133
Primary Data and Information Gathering 133
Secondary data and information gathering 134
Definitions of Product-Life Cycle stages 136
Glossary of abbreviations and acronyms 137
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: Pharmaceutical market by selected Central and Eastern European countries, 2007 84
Figure 3.15: Clinical trials Europe 90
Figure 3.16: Clinical trials by phase (no trials) in the Czech Republic, 2008 91
Figure 3.17: Clinical trials market ($m) in Poland, 2007-2010 92
Figure 3.18: Clinical trials by therapy area (%) in Russia, 2008 93
Figure 3.19: Clinical trials by phase (%) in Russia, 2008 94
Figure 3.20: FDA inspection deficiencies in Russian sites 101
List of Tables
Table 2.1: Demographics of selected emerging markets, 2007 40
Table 2.2: Ethical principles & their application for research 62
Table 3.3: Central and Eastern Europe population projection (m people), 2009 79
Table 3.4: Population statistics - Russia 80
Table 3.5: Principle city population statistics - Russia, 2008 81
Table 3.6: Estimated total deaths (thousands) by cause and by selected country 83
Table 3.7: Top 10 pharmaceutical companies ($m) in Russia, Poland and the Czech Republic, 2008 85
Table 3.8: Major CROs operating in Eastern Europe (including Poland and Czech Republic), 2009 87
Table 3.9: Top 10 Russian regions by no. of new investigative sites, 2006-2008 93
Table 3.10: Snapshot of hospitals in the Czech Republic 103
Table 3.11: Snapshot of hospitals in Poland 105
Table 3.12: Contact details regulatory authorities in selected Central and Eastern European countries 109
Table 3.13: Fees for clinical trial application (euro) in the Czech Republic, April 2009 113
Table 3.14: Guidelines and Forms for Clinical Trials Czech Republic 114
Table 3.15: Checklist of documents for initial application in Czech Republic 115
To order this report:
Drug Discovery and Development Industry: Emerging Clinical Trial Locations - Eastern Europe: Market dynamics and the changing healthcare and regulatory environment
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