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Reportlinker Adds Emerging Clinical Trial Locations - Eastern Europe: Market Dynamics and the Changing Healthcare and Regulatory Environment

NEW YORK, Dec. 1 /PRNewswire/ -- 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

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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Nicolas Bombourg
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Intl: +1 805-652-2626

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