Outsourcing Clinical Trials
Overview
Offshoring clinical trials to emerging markets around the world is receiving increasing attention as a very attractive alternative in the clinical development process. This follows as a natural reaction to already successful offshoring activities in the IT industry. The big question is: Do clinical research capabilities comparable to the US in terms of sophistication and FDA-compliance exist anywhere else in the world? And if they do, are they ready to handle the huge surge in business likely headed their way?
Outsourcing Clinical Trials: A Global Analytical Guide and Comparative Analysis of International Destinations, with Location Attractiveness Index analyzes the key drivers that have made the search for effective clinical trial outsourcing a necessity rather than an option in today's drug development efforts. The current climate of clinical trials in emerging markets across the world is examined. Geographic areas covered include Central and Eastern Europe, Latin America, Australia and New Zealand, Africa, Asia and India.
The report also includes the Clinical Trial Outsourcing Global Attractiveness Index. This vital piece of original research includes tables and graphs which rank international locations, according to the following criteria:
- Study Cost Indicators
- Patient Indicators
- Disease Indicators
- Clinical Research Indicators
- Research Personnel Indicators
- Study Site Indicators
- Business Environment Indicators
The index serves as an invaluable starting resource for pharmaceutical companies seeking to outsource their clinical trial functions to international destinations.
Each region covered in this report includes the following sub-sections, which break down, in depth, the factors vital to an understanding of international clinical trial outsourcing destinations:
- Location
- Target Population
- Alternative Medicine
- Disease Demographics
- Study Investigator Profile
- Study Site Characteristics
- Regulatory Climate
- Study Costs
- Clinical Trial Activity
- Pharmaceutical Market
- Key Market Advantages/Strengths
- Key Market Disadvantages/Weaknesses
- Report Recommendations
Reasons to buy this report:
- Focused only on outsourcing of clinical trials – This is the primary short-term focus of Pharma companies in developed nations. Content is not diluted by an excessive discussion of US-based clinical trials or US-based CROs or by too broad an analysis of overall pharma outsourcing
- Provides in depth analysis as to why particular regions are becoming preferred destinations for Pharma outsourcing in general and clinical trials in particular
- Provides objective comparative analysis of regions/countries and their potential as clinical trial destinations. This analysis assesses individual destination strengths with regard to scientific merit, technical capability, manpower, facilities, etc.
- Prepared by an experienced team of authors who have a deep understanding of industry dynamics and also have innumerable sources within the pharma industry to help the reader gain the “insider†advantage
Table of Contents
- Table of Contents
- 1Introduction
- 1.1China – A Key Emerging Destination for Clinical Trial Outsourcing
- 1.2India – From Technology Outsourcing to Clinical Trials
- 1.3Report Scope
- 2Pharma Productivity: Attitudinal Changes Across the Industry
- 2.1Key Trends Affecting Pharma Industry
- 2.2Current Strategies to Stimulate Growth and Control Costs
- 2.3Reasons for Decreasing Pharma R&D Productivity
- 2.4The Contract Research Outsourcing Market: Rising
- 2.5The Rise of Site Management Organizations (SMOs)
- 2.6Increased Workloads and Shortages of Clinical Resources has US Pharma Looking Abroad
- 2.7The CRO Share of the Outsourcing Market
- 2.8Globalization of the CRO Market
- 2.9CROs and the Need for Improved Patient Recruitment
- 3Clinical Trials in Central and Eastern Europe (CEE)
- 3.1Introduction
- 3.2Location
- 3.3Target Population
- 3.4Alternative Medicine
- 3.5Disease Demographics
- 3.6Study Investigator Profile
- 3.7Study Site Characteristics
- 3.8Regulatory Climate
- 3.9Study Costs
- 3.10Clinical Trial Activity
- 3.11Pharmaceutical Market
- 3.12Key Market Advantages/Strengths
- 3.13Key Market Disadvantages/Weaknesses
- 3.14Recommendations
- 4 Clinical Trials in Asia
- 4.1Introduction
- 4.2Location
- 4.3Target Population
- 4.4Alternative Medicine
- 4.5Disease Demographics
- 4.6Study Investigator Profile
- 4.7Study Site Characteristics
- 4.8Regulatory Climate
- 4.9Study Cost
- 4.10Clinical Trials Activity
- 4.11Pharmaceutical Market
- 4.12Key Market Advantages/Strengths
- 4.13Key Market Disadvantages/Weaknesses
- 4.14Report Recommendations
- 5Clinical Trials in India
- 5.1Introduction
- 5.2Location
- 5.3Target Population
- 5.4Alternative Medicine
- 5.5Disease Demographics
- 5.6Study Investigator Profile
- 5.7Study Site Characteristics
- 5.8Regulatory Climate
- 5.9Study Cost
- 5.10Clinical Trials Activity
- 5.11Pharmaceutical Market
- 5.12Key Market Advantages/Strengths
- 5.13Key Market Disadvantages/Weaknesses
- 5.14Recommendations: Strategies for Securing a Share of the Indian Market
- 6Clinical Trials in Australia and New Zealand (ANZ)
- 6.1Introduction
- 6.2Location
- 6.3Target Population
- 6.4Alternative Medicine
- 6.5Disease Demographics
- 6.6Study Investigator Profile
- 6.7Study Site Characteristics
- 6.8Regulatory Climate
- 6.9Study Costs
- 6.10Clinical Trial Activity
- 6.11Pharmaceutical Market
- 6.12CRO activity
- 6.13Key Market Advantages/Strengths
- 6.14Key Market Disadvantages/Weaknesses
- 6.15Recommendations
- 7Clinical Trials in Africa
- 7.1Introduction
- 7.2Location
- 7.3Target Population
- 7.4Alternative Medicine
- 7.5Disease Demographics
- 7.6Study Investigator Profile
- 7.7Study Site Characteristics
- 7.8Regulatory Climate
- 7.9Study Costs
- 7.10Clinical Trial Activity
- 7.11Pharmaceutical Market
- 7.12Key Market Advantages/Strengths
- 7.13Key Market Disadvantages/Weaknesses
- 7.14Recommendations
- 8Clinical Trials in Latin America
- 8.1Introduction
- 8.2Location
- 8.3Target Population
- 8.4Alternative Medicine
- 8.5Disease Demographics
- 8.6Study Investigator Profile
- 8.7Study Site Characteristics
- 8.8Regulatory Climate
- 8.9Study Costs
- 8.10Clinical Trial Activity
- 8.11Pharmaceutical Market
- 8.12Key Market Advantages/Strengths
- 8.13Key Market Disadvantages/Weaknesses
- 8.14Recommendations
- 9Clinical Trial Outsourcing Location Attractiveness Index: A Comparative Analysis of International Destinations
- 9.1Study Cost Indicators
- 9.2Patient Indicators
- 9.3Disease Indicators
- 9.4Clinical Research Indicators
- 9.5Research Personnel Indicators
- 9.6Study Site Indicators
- 9.7Business Environment Indicators
- 9.8Overall 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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