Outsourcing Clinical Trials: A Global Analytical Guide and Comparative Analysis of International Destinations, with Location Attractiveness Index

Published by: Arrowhead Publishers

Published: May. 1, 2007 - 215 Pages

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

Abstract

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

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