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

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


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