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Reportlinker Adds Emerging Clinical Trial Locations - India: 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 - India: 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 India.

Table of Contents

Emerging clinical trial locations - India

Executive summary 10

Introduction 10

Conducting clinical trials in emerging markets 11

India 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 India 74

Summary 74

Introduction 75

Geographic 75

Political 75

Economic 75

Market dynamics 76

Vital statistics 76

Population statistics 77

Epidemiology and prevalence of major disease 79

Pharmaceutical market 80

Biotechnology market 83

CRO market 84

Clinical trial market 88

Geographic focus of the Indian clinical research industry 88

Market drivers 91

Population ethnicity and genetic diversity 91

Large complement of trained medical specialists in India 92

Significant cost savings 93

Government incentives 94

Creation of the Clinical Trials Registry - India (CTRI) 95

Sophisticated logistics and clinical research infrastructure 95

Comprehensive IT and IT enabled support (ITES) base 96

Key barriers 97

Ethical issues 97

Lack of experienced investigators 98

Inability to detect and monitor ADRs 98

Bribery and corruption 99

Healthcare 99

Healthcare system 99

National level 99

State level 100

Regional level 100

District level 101

Sub-divisional/Taluka level 101

Community level 101

Primary health centre (PHC) level 101

Sub health centre (SHC) level 102

Hospital resources 102

Regulation and legislation 103

Regulatory authorities 103

The Ministry of Health and Family Welfare 103

Central Drug Standard Control Organization (CDSCO) 107

Drug Controller General of India (DCGI) 108

Indian Council of Medical Research (ICMR) 108

Clinical trial regulation 109

Harmonization of the clinical trial approval process 111

Legislation 112

Patent law and WTO TRIPS 112

Schedule Y Drugs and Cosmetics Act and Rule 114

Summary of the recent regulatory and legislative changes 115

Evolution of the regulatory environment 116

Expected improved collaboration: DCGI with international agencies 118

Anticipation of approval for early phase studies in India 118

Registration and regulation of CROs in India 119

Future reform and emphasis on improved pharmacovigilance in

India 120

India to implement an electronic management system 120

Outlook 122

Chapter 4 Appendix 124

Introduction to clinical trials 124

Clinical trial phases 124

Phase I 124

Phase II 124

Phase III 125

Phase IV 125

What is a clinical trial 125

Clinical trials of pharmaceutical agents 126

Types of clinical trial 127

Pilot studies 127

Proof of concept (PoC) trials 127

Randomized clinical studies 127

Controlled clinical trials 127

Parallel studies 128

Parallel group trials 128

Cohort studies 128

Case control studies 128

Role of the chief investigator 129

Clinical trial protocol and procedure 129

Determination of the clinical trial size 130

Role of the coordinating centre and trials unit 130

Role of the trial coordinator 130

The trial principle investigator 131

Forms and data management 131

Trial data analysis and evaluation 132

Ethical issues and conduct of clinical trial research 132

Interpretation and publication of clinical trial results 133

Principle regulatory agencies 133

The European Agency for the Evaluation of Medicinal Products (EMEA) 133

The United States Food and Drug Administration (US FDA) 133

Japanese Ministry of Health, Labor and Welfare (MHLW) 134

Methodology statement 135

Primary Data and Information Gathering 135

Secondary data and information gathering 136

Definitions of Product-Life Cycle stages 138

Glossary of abbreviations and acronyms 139

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: GDP in India (%) by sector 76

Figure 3.15: Projected growth of healthcare industry in India ($bn), 2008-2022 77

Figure 3.16: Population projection (millions) in India, 2000-2020 78

Figure 3.17: Pharma industry in India ($bn), 2007-2010 81

Figure 3.18: Market share (%) between MNCs and local pharmaceutical companies in India, 2003- 2007 82

Figure 3.19: Outsourced clinical trial market in India (US$), 2002-2010 87

Figure 3.20: Clinical trials in India (by phase), 2009 88

Figure 3.21: Types of disease and types of hospitals in India 91

Figure 3.22: Cost of clinical trials (%) in India vs US 94

Figure 3.23: Structure of healthcare system in India 100

Figure 3.24: Current organogram of the Ministry of Health and Family Welfare 105

Figure 3.25: Proposed organogram of the Ministry of Health and Family Welfare 106

Figure 3.26: Approval categories of global clinical trials in India 111

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: Statistical healthcare data India 78

Table 3.4: Ten leading causes of death (%) in India, 2002 79

Table 3.5: Diseases of the developed world in India 80

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

Table 3.7: Major biotechnology products in India and their companies 84

Table 3.8: Major CROs operating in India 86

Table 3.9: Major specialty hospital groups operating in Northern India 89

Table 3.10: Regulatory authorities based in Northern India 90

Table 3.11: Snapshot of hospitals in India 102

To order this report:

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

More Market Research Report

Nicolas Bombourg
US: (805)652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker

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