Table of Contents
1 Introduction
- 1.1 China - A Key Emerging Destination for Clinical Trial Outsourcing
- 1.2 India - From Technology Outsourcing to Clinical Trials
- 1.3 Report Scope
2 Pharma Productivity: Attitudinal Changes Across the Industry
- 2.1 Key Trends Affecting Pharma Industry
- 2.2 Current Strategies to Stimulate Growth and Control Costs
- 2.3 Reasons for Decreasing Pharma R&D Productivity
- 2.4 The Contract Research Outsourcing Market: Rising
- 2.5 The Rise of Site Management Organizations (SMOs)
- 2.6 Increased Workloads and Shortages of Clinical Resources has US Pharma
Looking Abroad
- 2.7 The CRO Share of the Outsourcing Market
- 2.8 Globalization of the CRO Market
- 2.9 CROs and the Need for Improved Patient Recruitment
3 Clinical Trials in Central and Eastern Europe (CEE)
- 3.1 Introduction
- 3.2 Location
- 3.3 Target Population
- 3.4 Alternative Medicine
- 3.5 Disease Demographics
- 3.6 Study Investigator Profile
- 3.7 Study Site Characteristics
- 3.8 Regulatory Climate
- 3.9 Study Costs
- 3.10 Clinical Trial Activity
- 3.11 Pharmaceutical Market
- 3.12 Key Market Advantages/Strengths
- 3.13 Key Market Disadvantages/Weaknesses
- 3.14 Recommendations
4 Clinical Trials in Asia
- 4.1 Introduction
- 4.2 Location
- 4.3 Target Population
- 4.4 Alternative Medicine
- 4.5 Disease Demographics
- 4.6 Study Investigator Profile
- 4.7 Study Site Characteristics
- 4.8 Regulatory Climate
- 4.9 Study Cost
- 4.10 Clinical Trials Activity
- 4.11 Pharmaceutical Market
- 4.12 Key Market Advantages/Strengths
- 4.13 Key Market Disadvantages/Weaknesses
- 4.14 Report Recommendations
5 Clinical Trials in India
- 5.1 Introduction
- 5.2 Location
- 5.3 Target Population
- 5.4 Alternative Medicine
- 5.5 Disease Demographics
- 5.6 Study Investigator Profile
- 5.7 Study Site Characteristics
- 5.8 Regulatory Climate
- 5.9 Study Cost
- 5.10 Clinical Trials Activity
- 5.11 Pharmaceutical Market
- 5.12 Key Market Advantages/Strengths
- 5.13 Key Market Disadvantages/Weaknesses
- 5.14 Recommendations: Strategies for Securing a Share of the Indian Market
6 Clinical Trials in Australia and New Zealand (ANZ)
- 6.1 Introduction
- 6.2 Location
- 6.3 Target Population
- 6.4 Alternative Medicine
- 6.5 Disease Demographics
- 6.6 Study Investigator Profile
- 6.7 Study Site Characteristics
- 6.8 Regulatory Climate
- 6.9 Study Costs
- 6.10 Clinical Trial Activity
- 6.11 Pharmaceutical Market
- 6.12 CRO activity
- 6.13 Key Market Advantages/Strengths
- 6.14 Key Market Disadvantages/Weaknesses
- 6.15 Recommendations
7 Clinical Trials in Africa
- 7.1 Introduction
- 7.2 Location
- 7.3 Target Population
- 7.4 Alternative Medicine
- 7.5 Disease Demographics
- 7.6 Study Investigator Profile
- 7.7 Study Site Characteristics
- 7.8 Regulatory Climate
- 7.9 Study Costs
- 7.10 Clinical Trial Activity
- 7.11 Pharmaceutical Market
- 7.12 Key Market Advantages/Strengths
- 7.13 Key Market Disadvantages/Weaknesses
- 7.14 Recommendations
8 Clinical Trials in Latin America
- 8.1 Introduction
- 8.2 Location
- 8.3 Target Population
- 8.4 Alternative Medicine
- 8.5 Disease Demographics
- 8.6 Study Investigator Profile
- 8.7 Study Site Characteristics
- 8.8 Regulatory Climate
- 8.9 Study Costs
- 8.10 Clinical Trial Activity
- 8.11 Pharmaceutical Market
- 8.12 Key Market Advantages/Strengths
- 8.13 Key Market Disadvantages/Weaknesses
- 8.14 Recommendations
9 Clinical Trial Outsourcing Location Attractiveness Index: A Comparative Analysis of International Destinations
- 9.1 Study Cost Indicators
- 9.2 Patient Indicators
- 9.3 Disease Indicators
- 9.4 Clinical Research Indicators
- 9.5 Research Personnel Indicators
- 9.6 Study Site Indicators
- 9.7 Business Environment Indicators
- 9.8 Overall Rank Scores
Tables
- Table 2.1 Patent Expirations Due on Blockbuster Drugs
- Table 2.2 Ways to Reduce Development Costs for a New Drug
- Table 2.3 Global Spending on Development and Clinical Services Outsourcing*
- Table 2.4 Clinical Study Activity Managed Worldwide by Major CROs
- Table 4.1 Overview of Patients Available for Clinical Trials in China
- Table 4.2 Clinical Trial Considerations in Asia
- Table 4.3 Investigative Sites/Hospitals in Selected Asian Countries
- Table 4.4 Regulatory Approval Times in Select Asian Countries
- Table 4.5 Regulatory Bodies in China Required for Clinical Trial Approval
- Table 4.6 Costs of Clinical Trials in China (in US$)
- Table 5.1 Urban India - Population
- Table 5.2 The Cost of Clinical Trials in India vs. the US
- Table 5.3 Top Pharmaceutical Companies' R&D and Manufacturing Offshoring
Activities and Ramp-up Plans in India
- Table 5.4 Indian CROs
- Table 5.5 Global CROs in India
- Table 5.6 Leading Service Providers
- Table 7.1 United Nations Definition of Major African Regions
- Table 7.2 Leading Causes of Death for Males and Females Aged between 15 to
59 (Estimates for 2000)
- Table 8.1 United Nations Definition of Latin American Regions
- Table 8.2 Selected Country Indicators in Latin America
- Table 8.3 Clinical Trials Information for the Six Key Clinical Trials
Location in Latin America*
- Table 8.4 Clinical Trials in Latin America 1966-2003
- Table 8.5 Clinical Trials in Latin America 2006
- Table 8.6 Approved Clinical Studies in Brazil, by Phase
- Table 9.1 Compensation Cost and Infrastructure Cost Indicators, by Country
- Table 9.2 Compensation Cost and Infrastructure Cost Comparative Indices,
by Country
- Table 9.3 Study Cost Index and Study Cost Rank Score
- Table 9.4 Patient Indicators, by Country
- Table 9.5 Population Indicator Index and Population Indicator Rank Score
- Table 9.6 Cardiovascular Disease Statistics
- Table 9.7 Pulmonary Disease Statistics
- Table 9.8 Cancer Disease Statitistics
- Table 9.9 Infectious Disease Statistics
- Table 9.10 Cardiovascular Disease Index
- Table 9.11 Pulmonary Disease Index
- Table 9.12 Cancer Index
- Table 9.13 Infectious Disease Index
- Table 9.14 Disease Index
- Table 9.15 Clinical Research Indicators, by Country
- Table 9.16 Clinical Research Index and Clinical Research Rank Score
- Table 9.17 Research Personnel Indicators, by Country
- Table 9.18 Research Personnel Index and Research Personnel Rank Score
- Table 9.19 Study Site Indicators, by Country
- Table 9.20 Study Site Index and Rank Score
- Table 9.21 Business Environment Indicators, by Country
- Table 9.22 Business Environment Index and Rank Score
- Table 9.23 Clinical Trial Global Attractiveness Index
Graphs
- Graph 2.1 Total Pharma R&D Expenditure (US$ billion)
- Graph 2.2 Total Pharma Clinical Outsourcing Expenditure (US$ billion)
- Graph 2.3 Global Clinical Research Personnel
- Graph 2.4 Pivotal Trial Milestones
- Graph 2.5 Case Report Form Queries/Page Screen
- Graph 2.6 Contract Research Organization Global Industry Revenues
- Graph 2.7 Location of New Offices for US-Based CROs
- Graph 3.1 Fee Partition
- Graph 3.2 Clinical Trials Registered in Western Pharmaceutical Companies
in Poland 1995-2001
- Graph 3.3 Clinical Trials Registered by Western Pharmaceutical Companies
in Hungary 1992-2000
- Graph 3.4 Drug Sales in the Eight New EU Member States in 2004
- Graph 4.1 Number of Human Clinical Trials in Selected Countries (2006)
- Graph 5.1 Cost Savings of Clinical Trials in India
- Graph 6.1 International Clinical Trials Cost Comparisons in Terms of
Overall Pharmaceutical Manufacturing Costs
- Graph 6.2 Mean Fee per Patient (in AU$)
- Graph 6.3 Schemes, Location and Phases of Clinical Trials in Australia
- Graph 7.1 Proposed EDCTP Expenditure (203-2007)
- Graph 8.1 Estimated Annual National Health Expenditure as a Proportion of
GDP in Select Latin American Countries
- Graph 8.2 Leading Causes of Death in Latin America
- Graph 8.3 Key Areas of Latin American Investigators' Expertise
- Graph 8.4 Most Common Pending Issues from the Brazilian Ministry of Health
- Graph 8.5 Therapeutic Breakdown of Current Clinical Research in Argentina
- Graph 8.6 Lilly Argentina' s Clinical Trial Activity (1997-2000)
- Graph 8.7 Pfizer Argentina' s Clinical Research Activity
- Graph 8.8 Sponsors of Clinical Research in Argentina
- Graph 8.9 Total Approved Clinical Studies in Brazil, by Year
- Graph 8.10 Latin American Pharmaceutical Market in 2005 by Key Countries
- Graph 9.1 Compensation Cost Indices
- Graph 9.2 Population Related Indices
- Graph 9.3 Cardiovascular Disease Index
- Graph 9.4 Pulmonary Index
- Graph 9.5 Cancer Index
- Graph 9.6 Infectious Disease Index
- Graph 9.7 Disease Incidence Index
- Graph 9.8 Clinical Research Rank Order
- Graph 9.9 Research Personnel Indicators, Rank Order
- Graph 9.10 Study Site Indices
- Graph 9.11 Business Environment Indices
- Graph 9.12 Clinical Trial Global Attractiveness Index
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