SPI Infoamtion

Table of Contents

1 Executive Summary
1.1 This Report Provides Crucial, Hard-to-Find Clinical Trials Data
1.2 Summary Points of This Report
1.3 Aims, Scope and Format of This Report
1.3.1 Market Growth or Rising Costs?
1.3.2 Chapter Outline
1.4 Research Methods

2 Introduction
2.1 Costs of Clinical Trials
2.2 A Brief History of Clinical Trials
2.2.1 The Nuremberg Code
2.2.2 The Declaration of Helsinki
2.2.3 Council for International Organizations of Medical Sciences (CIOMS)
2.2.4 Establishing International Standards for Good Clinical Practice
2.2.5 The FDA's New Rules for Acceptable Foreign Clinical Studies
2.3 Pre-Clinical Drug Studies
2.3.1 Animal Models
2.3.2 The FDA's Phase 0
2.4 Standard Clinical Phases: Phase I-III Trials
2.4.1 Phase I Trials
2.4.2 Phase II Trials
2.4.3 Phase III Trials
2.4.4 Phase IV Trials: Post-Marketing Surveillance
2.5 Basic Principles in Clinical Trials Design
2.5.1 The Placebo Effect
2.5.2 Inclusion Criteria and Exclusion Criteria
2.5.3 Randomisation of Subjects
2.5.4 Blinded Trials
2.5.5 Endpoints
2.6 Adaptive Clinical Trial Designs
2.6.1 Adaptive Trials and Staging
2.6.2 Adaptive Trials and Blending Phases
2.6.3 Adaptive Trials, the FDA and the EMEA
2.6.4 Academia Setting the Standard?
2.7 Clinical Trials and Genetic Tests
2.7.1 Genetics and Micro-Arrays
2.7.2 Toxicity Libraries
2.8 Clinical Data Management Systems
2.8.1 Clinical Trials Data Management Systems: Electronic Data Capture
2.8.2 Hurdles Faced by Investigators in Implementing EDC
2.8.3 Clinical Data Interchange Standards Consortium

3 Clinical Trials Market
3.1 World Market for Clinical Trials
3.2 Changing Market Share Percentages
3.3 US and Canada: Growing in Revenues but Losing Market Share by 2024
3.3.1 North America Market Share Through to 2024
3.4 Western Europe Revenue Trends
3.4.1 Western Europe Market Share Through to 2024
3.5 Central and Eastern Europe (CEE) and Russia Revenue Trends
3.5.1 CEE and Russia Market Share Rising Significantly Through to 2019
3.5.2 Russia
3.6 India: The Fastest-Growing Outsourcing Destination?
3.6.1 India's Market Share Growing Rapidly
3.7 China: Promising but Challenging Market
3.7.1 China's Market Share Growing Through to 2024

4 The Trend Towards Outsourcing and Off-Shoring
4.1 More International Investigation Sites Registering for FDA Approval
4.2 How Countries Invite More Trials
4.3 How Foreign Clinical Trials Help Host Countries
4.4 Ongoing Challenges for Emerging Outsourcing Markets
4.5 Questions about Genetic / Ethnic Differences and Relevance
4.5.1 New Discoveries Possible Through International Trials and Genetic Variation
4.6 Questions About Ethics in Outsourced Trials
4.7 Institute of Clinical Research (India)
4.7.1 Institute of Clinical Research (India) (ICRI): Assuring Ethics
4.7.2 Pfizer's Ethics Accreditation
4.8 India as Case-Study
4.8.1 Benefits and Concerns of India as an Outsource Location
4.8.2 India Needs More Research Personnel
4.8.3 Short- and Long-Term Personnel Goals
4.9 Interview with Dr Arun Bhatt, President, Clininvent Research
4.9.1 Dr Bhatt on the Benefits and Complexities of Clinical Trials in India
4.9.2 Tested Drugs Marketed in India?
4.9.3 Marketing and the Need for Harmonisation

5 Contract / Clinical Research Organisations (CROs)
5.1 CROs Gaining Market Share Through to 2024
5.2 Value of CROs Rising Threefold by 2024
5.3 Year-Over-Year Growth Percentages for CROs: Average over 16%
5.4 Quintiles
5.4.1 Quintiles Highest-Rated in Industry Standards Research Survey
5.4.2 Quintiles Opening Phase I Facility in India
5.4.3 Quintiles and SAS: New Certification
5.5 Pharmaceutical Product Development, Inc. (PPD)
5.6 Covance
5.6.1 Covance and Eli Lilly
5.7 Pharsight Corporation: Crucial Software and Modelling Techniques
5.7.1 Fiscal Year 2009, Quarter 1: Financial Results Up from 2008
5.7.2 Pharsight's Products Used by the FDA
5.7.3 Pharsight in China: Agreement with InforSense
5.8 Amarex
5.9 Kendle
5.9.1 Kendle and DecisionLine
5.10 MDS Pharma Services
5.10.1 MDS Pharma Expanding in Taiwan
5.10.2 MDS and Compendia Biosciences, Inc.: Facilitating Cancer Therapies
5.11 Clininvent / TCG Lifesciences
5.12 Parexel
5.13 PharmaNet Development Group (formerly SFBC International Inc.)
5.13.1 PharmaNet Purchased by JLL Partners in February 2009
5.14 ReSearch Pharmaceutical Services (RPS)
5.14.1 RPS Acquires 4 CROs in 4 Months
5.15 ICON Plc
5.15.1 ICON Partners with Eli Lilly
5.15.2 ICON Acquires New Phase I Facility
5.16 PRA International
5.17 Omnicare Clinical Research
5.18 The Clinical Trial Company (TCTC)
5.19 Chiltern International, Ltd.
5.19.1 Chiltern Acquires Vigiun
5.20 Averion International Corp.
5.20.1 Averion Doubled Workforce by Acquiring Hesperion
5.21 Veeda Clinical Research
5.22 Synexus

6 Interviews with Experts
6.1 Interview with Dr Nathaniel Katz, MD., MS., Founder of Analgesic Research (Interview conducted 18 June 2009)
6.1.1 On the Emphasis on Biomarkers
6.1.2 On the Inadequacies of Some Objective Endpoints
6.1.3 On the Need for Root-Cause Analysis of Clinical Trials Inefficiencies
6.1.4 On Reducing Sample Size
6.1.5 On Sample Size and Reliable Measures
6.1.6 On Measures of Reporting: Reliability and Validity
6.1.7 On Improving Efficiency by Improving Research Methods Themselves
6.1.8 On the Fundamental Problems of Current Patient Recruiting Paradigms
6.1.9 On the New Recruitment Paradigm: Engaging Patients and Pre-Trial Recruitment
6.1.10 On Assessing Patient Motivations
6.1.11 On Proof-of-Concept Studies as Major Efficiency Bottlenecks
6.1.12 On Adaptive Trials and Combining Phases
6.1.13 On Experimental Models and Their Limitations
6.1.14 On the Over-Emphasis on Technology
6.1.15 On the Need for Pharmaceutical Companies to Invest in New Recruitment Paradigms
6.1.16 On Using Patients Efficiently and as Experts
6.1.17 On the Benefits of Early-Stage Focus Groups for Later-Stage Trials, for Development and for Marketing
6.2 Interview with Dr Kevin Dykstra, PhD. Senior Vice President, Worldwide Strategic Consulting Services for Pharsight (Interview Conducted 9 June 2009)
6.2.1 On the Promises and Problems of Adaptive Trials
6.2.2 On the Limits of Trials Adaptation
6.2.3 On The Selection of Efficacy Endpoints
6.2.4 On Signal Discovery Times and Biomarkers
6.2.5 On Trial Adjustments and Endpoints
6.2.6 On Pharsight's “Clinical Utility” Approach to Development Strategies
6.2.7 On Software Innovations and Trials Efficiency
6.2.8 On Phased Development Becoming or Not Becoming Obsolete
6.2.9 On Combining Phase II and III Trials
6.2.10 On the Future and Usefulness of Placebo Models and Datasharing
6.2.11 On Databases of Drugs' Mechanisms

7 SWOT Analysis of the Global Clinical Trials Market
7.1 Overall Strengths and Weaknesses in 2009
7.2 Overall Opportunities and Threats Through to 2024
7.2.1 The Impact of Thin Pipelines
7.2.2 Outsourcing Drug Discovery
7.2.3 The Impact of Specialised Medicines
7.2.4 The Decline of the Blockbuster Model
7.3 Different Perspectives on Costs / Threats: Pharmaceutical Companies and CROs
7.3.1 Increasing Competition: Potential Threat to CROs
7.4 Different Perspectives on Benefits / Gains: Pharmaceutical Companies and CROs

8 Conclusions
8.1 The Demand for Late- versus Early-Stage Trials
8.2 The Growth of CROs
8.2.1 Increasing Competition Among CROs
8.2.2 Increased Regional Competition
8.3 The Short-Term Future
8.4 The Long-Term Future

List of Tables
Table 2.1 Key Stages in the History of Clinical Trials
Table 3.1 Total Market Forecasts ($m), 2009-2024, Showing Regional Forecasts
Table 3.2 US and Canada Market Forecast ($m), 2009-2024
Table 3.3 Costs and Benefits of Conducting Clinical Trials in North America
Table 3.4 Western Europe Market Forecast ($m), 2009-2024
Table 3.5 Costs and Benefits of Conducting Clinical Trials in CEE Countries
Table 3.6 CEE and Russia Market Forecast ($m), 2009-2024
Table 3.7 India Market Forecast ($m), 2009-2024
Table 3.8 China Market Forecast ($m), 2009-2024
Table 3.9 Costs and Benefits of Conducting Clinical Trials in China
Table 4.1 Some Countries Actively Funding Drug Development Infrastructure
Table 4.2 Benefits and Challenges to Outsource Host Countries
Table 4.3 Benefits and Concerns with Running Clinical Trials in India
Table 5.1 CROs and Direct Industry Funding Market Forecast ($bn), 2009-2024
Table 5.2 Year-Over-Year Growth (%) for Selected CROs, 2007-2008
Table 7.1 Strengths and Weaknesses in Clinical Trials Market, 2009
Table 7.2 Opportunities and Threats for the Future Clinical Trials Market, 2009-2024
Table 7.3 Pharmaceutical Companies’ and CROs’ Perspectives on Costs and Threats
Table 7.4 Pharmaceutical Companies’ and CROs’ Perspectives on Benefits and Gains
Table 8.1 Trials Breakdown Forecast in 5-Year Increments (by Phase), 2009-2024

List of Figures
Figure 2.1 Drug Development Progression
Figure 3.1 Market Forecast ($bn) for Top 3 Regions, 2009-2024
Figure 3.2 Market Forecast ($m) for Lower 3 Regions, 2009-2024
Figure 3.3 Regional Market Share (%) 2009
Figure 3.4 Regional Market Share (%) 2014
Figure 3.5 Regional Market Share (%) 2019
Figure 3.6 Regional Market Share (%) 2024
Figure 3.7 US and Canada Market Forecast ($bn), 2009-2024
Figure 3.8 US and Canada Market Share Forecast (%), 2009-2024
Figure 3.9 Western Europe Market Forecast ($bn), 2009-2024
Figure 3.10 Western Europe Market Share Forecast (%), 2009-2024
Figure 3.11 CEE and Russia Market Forecast ($bn), 2009-2024
Figure 3.12 CEE and Russia Market Share Forecast (%), 2009-2024
Figure 3.13 India Market Forecast ($m), 2009-2024
Figure 3.14 India Market Share Forecast (%), 2009-2024
Figure 3.15 China Market Forecast ($m), 2009-2024
Figure 3.16 China Market Share Forecast (%), 2009-2024
Figure 5.1 CROs Market Share Forecast (%), 2009-2024
Figure 5.2 CROs Value Forecast ($bn), 2009-2024
Figure 5.3 Year-Over-Year Growth (%) for Selected CROs, 2007-2008