Reportlinker Adds Emerging Clinical Trial Locations - China: Market dynamics and the changing healthcare and regulatory environment

Wednesday, December 2, 2009 General News
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NEW YORK, Dec. 1 announces that a new market research report is available in its catalogue:

Emerging Clinical Trial Locations - China: 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 China.

Table of Contents

Emerging clinical trial locations - China

Executive summary 10

Introduction 10

Conducting clinical trials in emerging markets 11

China 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 China 74

Summary 74

Introduction 75

Geographic 75

Political 75

Economic 76

Market dynamics 78

Vital statistics 78

Population statistics 78

Epidemiology and prevalence of major disease 78

Pharmaceutical market 80

CRO market 82

Overseas CROs 84

Joint venture companies 85

Local CROs 86

Clinical trial market 88

Market drivers 89

Rapid patient recruitment from large pool of treatment naïve patients 89

Well-trained and motivated clinical trial investigators 89

Major cost savings 89

Increasing importance of the pharmaceutical market in China 90

US government opens FDA offices in China 91

Financial support and incentives from the Chinese government 92

Creation of the Chinese Clinical Trial Register (CHiCTR) 92

Key barriers 94

Cultural and linguistic 94

Delays to application and gaining approval 94

Due diligence required to ensure intellectual property protection 95

Issues over importation and importation licenses 95

Monitor compliance of SFDA GCP with ICH GCP 95

Healthcare 96

Healthcare system 96

Overview 96

Healthcare reforms 98

Healthcare institutions 99

Hospital resources 100

Regulation 102

Regulatory authorities 102

State Food and Drug Administration (SFDA) 102

Department of drug registration 103

Clinical trial regulation 104

Application and approval of the new drug clinical trial study 104

Registration approval for the manufacture of the new drug for market 105

Legislation 108

Patent Law and WTO TRIPS 108

Drug Administration Law of the People's Republic of China 111

Outlook 115

Chapter 4 Appendix 118

Introduction to clinical trials 118

Clinical trial phases 118

Phase I 118

Phase II 118

Phase III 119

Phase IV 119

What is a clinical trial 119

Clinical trials of pharmaceutical agents 120

Types of clinical trial 121

Pilot studies 121

Proof of concept (PoC) trials 121

Randomized clinical studies 121

Controlled clinical trials 121

Parallel studies 122

Parallel group trials 122

Cohort studies 122

Case control studies 122

Role of the chief investigator 123

Clinical trial protocol and procedure 123

Determination of the clinical trial size 124

Role of the coordinating centre and trials unit 124

Role of the trial coordinator 124

The trial principle investigator 125

Forms and data management 125

Trial data analysis and evaluation 126

Ethical issues and conduct of clinical trial research 126

Interpretation and publication of clinical trial results 127

Principle regulatory agencies 127

The European Agency for the Evaluation of Medicinal Products (EMEA) 127

The United States Food and Drug Administration (US FDA) 127

Japanese Ministry of Health, Labor and Welfare (MHLW) 128

Methodology statement 129

Primary Data and Information Gathering 129

Secondary data and information gathering 130

Definitions of Product-Life Cycle stages 132

Glossary of abbreviations and acronyms 133

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: Administrative divisions of the People's Republic of China 77

Figure 3.15: Pharma market in China ($), 2007-2008 81

Figure 3.16: CRO market in China (US$), 2007-2012 83

Figure 3.17: Cost of clinical trials (%) in China vs western countries 90

Figure 3.18: The Chinese Healthcare System 97

Figure 3.19: NRCMCS medical cover cost and benefits in China 99

Figure 3.20: Current drug approval and evaluation process in China 105

Figure 3.21: Application and approval procedure for clinical trials China 107

Figure 3.22: Location of accredited sites for clinical trials in China 113

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: China Population Projections (m people), 1950-2050 79

Table 3.4: Ten leading causes of death in China, 2002 79

Table 3.5: Prevalence of major cancers in China, 2007 80

Table 3.6: Top 10 pharmaceutical companies ($m) in China, 2008 82

Table 3.7: Major multinational CROs operating in China 84

Table 3.8: Local Chinese owned CROs 87

Table 3.9: Number of healthcare institutions according to ownership China 100

Table 3.10: Total number of hospitals by ranking China 101

Table 3.11: Chinese government agencies responsible for drug regulation 102

To order this report:

Drug Discovery and Development Industry: Emerging Clinical Trial Locations - China: Market dynamics and the changing healthcare and regulatory environment

More Market Research Report

Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626

SOURCE Reportlinker

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