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Reportlinker Adds Emerging Clinical Trial Locations - Eastern Europe: Market Dynamics and the Changing Healthcare and Regulatory Environment
Date:12/1/2009

ion 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


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