Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies

Published by: Business Insights

Published: Jan. 1, 2010 - 250 Pages

Table of Contents

Investigating clinical trial costs: Comparative analysis of trial cost components in key geographies

Executive summary

Introduction and background to clinical trials

Financial considerations & planning of clinical trials

Cost analysis of clinical trial authorization by responsible authorities

Cost analysis of clinical trial review by ethics committees

Review and cost analysis of investigator fees by selected country

Review and cost analysis of laboratory fees, pharmacy costs and clinical

trial liability insurance by selected country

Review and cost analysis of CRO salaries by selected country

Chapter 1 Introduction and background to clinical trials

Summary

Introduction and background to pharmaceutical industry issues

High risks and costs associated with drug development

Escalating costs associated with clinical trials

Global increase in the number of clinical trials conducted

Longer R&D timelines

Increased attrition rates during pharmaceutical research and development

Improvement to R&D productivity and reducing time to market for next generation drugs

New business models for the pharmaceutical industry

Introduction to clinical trials and clinical trial studies

What is a clinical trial

Clinical trials of pharmaceutical agents

Types of clinical trial

Drug development process

Drug discovery

Preclinical development

Clinical trial phases

The role of the chief investigator

Clinical trial protocol and procedure

Determination of the clinical trial size

The role of the co-coordinating centre and trials unit

The role of the trial co-coordinator

The trial principal investigator

Forms and data management

Trial data analysis and evaluation

Ethical issues and conduct of clinical trail research

Interpretation and publication of clinical trial results

Clinical trial study design and planning

Clinical trial study design

Clinical trial study protocol

Clinical trial sponsors

Identifying and recruiting patients for clinical trials

Contract research organizations (CRO)

What are CROs

The role of CROs

Principle pharmaceutical and pharmaceutical regulatory agencies

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

The United States Food and Drug Administration (US FDA)

Japanese Ministry of Health, Labor and Welfare (MHLW)

Chapter 2 Financial considerations and planning of clinical trials

Summary

Introduction

Key variables to consider for resource budgeting and allocation

Elements of successful budgeting

Development of the clinical trial protocol

Design and planning the clinical trial

Clinical trial design

Clinical trial planning

Multi-purpose studies

Clinical trial budget development process and cost analysis

Direct costs

Commonly overlooked clinical trial budget items

Chapter 3 Cost analysis of clinical trial authorization by responsible authorities

Summary

Introduction

Authorization process for clinical trials

European authorization process for clinical trials

Comparison of fees incurred: in the principal Western European countries

France

Germany

Italy

Spain

United Kingdom

Selected other Western European countries

Denmark

Sweden

Finland

Norway

The Netherlands

Comparison of fees incurred in the principal Central and Eastern

European countries

Russia

Czech Republic

Poland

Hungary

Comparison of fees incurred in the principal Latin American countries

Argentina

Brazil

Mexico

Comparison of fees incurred in the principal Asian countries

India

Application and authorization process fees: India

China

Authorization process for clinical trials: United States

Chapter 4 Cost analysis of clinical trial review by ethics committees

Summary

Introduction

Fees for assessment of clinical trial applications by Research Ethics

Committees (ECS) in the principal Western European countries

France

Germany

Italy

Spain

United Kingdom

Selected other Western European countries

Denmark

Sweden

Finland

Norway

The Netherlands

Fees for assessment of clinical trial applications by research ethics committees in the principal Central and Eastern European countries

Russia

Czech Republic

Poland

Hungary

Fees for assessment of clinical trial applications by research ethics committees in the principal Latin American countries

Argentina

Brazil

Mexico

Fees for assessment of clinical trial applications by research ethics committees in the principal Asian countries

India

China

Fees for assessment of clinical trial applications by research ethics committees (RECs) in the United States

Chapter 5 Review and cost analysis of investigator fees by selected country

Summary

Introduction

Analysis of investigator fees: Phase I

Review and cost analysis of investigator fees in the principal Western European countries (Phase I)

Review and cost analysis of investigator fees in selected Central and Eastern European countries (Phase I)

Review and cost analysis of investigator fees in the selected Latin American countries (Phase I)

Review and cost analysis of investigator fees in the selected Asian countries (Phase I)

Review and cost analysis of investigator fees in the United States for Phase I and comparison with other selected countries

Analysis of investigator fees: Phase II

Review and cost analysis of investigator fees in the principal Western European countries (Phase II)

Review and cost analysis of investigator fees in the selected Central andEastern European countries (Phase II)

Review and cost analysis of investigator fees in the selected Latin American countries (Phase II)

Review and cost analysis of investigator fees in selected Asian countries (Phase II)

Review and cost analysis of investigator fees in the United States for Phase II and comparison with other selected countries

Analysis of investigator fees: Phase III

Review and cost analysis of investigator fees in the selected Central and Eastern European countries (Phase III)

Review and cost analysis of investigator fees in the selected Latin American countries (Phase III)

Review and cost analysis of investigator fees in selected Asian countries (Phase III)

Review and cost analysis of investigator fees in the United States for Phase III and comparison with other selected countries

Analysis of investigator fees: Phase IV

Review and cost analysis of investigator fees in the selected Central and Eastern European countries (Phase IV)

Review and cost analysis of investigator fees in the selected Latin American countries (Phase IV)

Review and cost analysis of investigator fees in selected Asian countries (Phase IV)

Review and cost analysis of investigator fees in the United States for Phase IV and comparison with other selected countries

Summary of investigator fees analysis: Phase I-IV, by therapeutic area and by selected geographic regions

Chapter 6 Review and cost analysis of laboratory fees, pharmacy costs and clinical trial liability insurance by selected country

Summary

Review and cost analysis of laboratory fees by selected country

Introduction

Laboratory fees: key variables

Review and cost analysis of laboratory fees in the principal Western European countries versus the United States

Review and cost analysis of laboratory fees in the principal Central and Eastern European countries versus the United States

Review and cost analysis of laboratory fees in the principal Latin American countries versus the United States

Review and cost analysis of laboratory fees in the principal Asian countries versus the United States

Other laboratory test costs and budget preparation fees

Review and cost analysis of pharmacy costs by selected country

Introduction

Comparison of pharmacy costs in the selected countries

Comparison of the average pharmacy fees in the selected geographic regions

Review and cost analysis of patient clinical trial liability insurance by selected country

Introduction

Comparison of clinical trial liability insurance requirements in the principal Western European countries

Comparison of clinical trial liability insurance requirements in the principal Central and Eastern European countries

Comparison of clinical trial liability insurance requirements in the principal Latin American countries

Comparison of clinical trial liability insurance requirements in the principal Asian countries

Clinical trial liability insurance requirements in the United States

Comparison of clinical trial liability insurance

Chapter 7 Review and cost analysis of CRO salaries by selected country

Summary

Evolution of the industry

Structure of CRO operating expenses reporting systems

Direct expenses

Research and development

Selling, general and administrative

Comparison of CRO salaries in the principal Western European countries

Comparison of CRO salaries in the principal Central and Eastern European countries

Comparison of CRO salaries in the principal Latin American countries

Comparison of CRO salaries in the principal Asian countries

Chapter 8 Appendix

Methodology statement

Primary data and information gathering

Secondary data and information gathering

Market share analysis and market forecast predictions

Definitions of product lifecycle stages

Glossary of abbreviations and acronyms

List of Figures

Figure 1.1: Key issues facing pharma and biotech companies

Figure 1.2: New Drug Approvals and R&D spending

Figure 1.3: Change in investment level by development phase between 2001 and 2007

Figure 1.4: Pharmaceutical research and development expenditure (2004-2009e)

Figure 1.5: Biotech R&D spending ($bn), 2004-2009e

Figure 1.6: Change in investment level by development phase, 2001-07

Figure 2.7: Overall clinical trial costs in various countries compared to the United States

Figure 2.8: Protocol target population checklist

Figure 2.9: Protocol feasibility checklist

Figure 2.10: Protocol budgetary considerations

Figure 2.11: Review and approval process for new clinical trials (Europe)

Figure 2.12: General review and approval process for new clinical trials (USA)

Figure 2.13: Budget process

Figure 3.14: Procedure for starting a clinical trial in the EU

Figure 3.15: Regulatory flowchart - Argentina

Figure 3.16: Regulatory flowchart - Brazil

Figure 3.17: Regulatory flowchart - Mexico

Figure 3.18: Application and approval procedure for clinical trials in China

Figure 4.19: Registered research ethics committees (REC) by Region - Brazil 2008

Figure 5.20: Key factors influencing the investigator fees

Figure 5.21: Relative cost per patient (CPP) by therapeutic area for investigators

Figure 5.22: Average per patient investigator fee ($) for Phase I by selected Western European countries, 2009

Figure 5.23: Average per patient investigator fee ($) for Phase I by therapeutic area, Western Europe, 2009

Figure 5.24: Average per patient investigator fee ($) for Phase I by selected Central and Eastern European countries, 2009

Figure 5.25: Average per patient investigator fee ($) for Phase I by therapeutic area in select CEE countries 2009

Figure 5.26: Average per patient investigator fee ($) for Phase I by selected Latin American countries, 2009

Figure 5.27: Average per patient investigator fee ($) for Phase I by therapeutic area in select Latin American countries, 2009

Figure 5.28: Average per patient investigator fee ($) for Phase I by selected Asian countries, 2009

Figure 5.29: Average per patient investigator fee ($) for Phase I by therapeutic area in select Asian countries, 2009

Figure 5.30: Average per patient investigator fee ($) for Phase I by selected countries, 2009

Figure 5.31: Average per patient investigator fee ($) for Phase I by therapeutic area, selected countries, 2009

Figure 5.32: Average per patient investigator fee ($) for Phase II by selected Western European countries, 2009

Figure 5.33: Average per patient investigator fee ($) for Phase II by therapeutic are in selected Western European countries, 2009

Figure 5.34: Average per patient investigator fee ($) for Phase II by selected CEE countries, 2009

Figure 5.35: Average per patient investigator fee ($) for Phase II by therapeutic area in selected CEE countries, 2009

Figure 5.36: Average per patient investigator fee ($) for Phase II by selected Latin American countries, 2009

Figure 5.37: Average per patient investigator fee ($) for Phase II by therapeutic area in select Latin American countries, 2009

Figure 5.38: Average per patient investigator fee ($) for Phase II in selected Asian, 2009

Figure 5.39: Average per patient investigator fee ($) for Phase II by therapeutic area in select Asian countries, 2009

Figure 5.40: Average per patient investigator fee ($) for Phase II in selected countries, 2009

Figure 5.41: Average per patient investigator fee ($) for Phase II in selected therapeutic areas,

Figure 5.42: Average per patient investigator fee ($) for Phase III in selected Western European countries, 2009

Figure 5.43: Average per patient investigator fee ($) for Phase III in selected Western European countries, by therapeutic area, 2009

Figure 5.44: Average per patient investigator fee ($) for Phase III in selected CEE countries, 2009

Figure 5.45: Average per patient investigator fee ($) for Phase III in selected CEE countries, by therapeutic area, 2009

Figure 5.46: Average per patient investigator fee ($) for Phase III in selected Latin American countries, 2009

Figure 5.47: Average per patient investigator fee ($) for Phase III in selected Latin American countries, by therapeutic area, 2009

Figure 5.48: Average per patient investigator fee ($) for Phase III in selected Asian countries, 2009

Figure 5.49: Average per patient investigator fee ($) for Phase III in selected Asian countries, by therapeutic area, 2009

Figure 5.50: Average per patient investigator fee ($) for Phase III by selected countries, 2009

Figure 5.51: Average per patient investigator fee ($) for Phase III by therapeutic area, in selected countries, 2009

Figure 5.52: Average per patient investigator fee ($) for Phase IV in selected Western European countries, 2009

Figure 5.53: Average per patient investigator fee ($) for Phase IV in selected Western European countries, by therapeutic area, 2009

Figure 5.54: Average per patient investigator fee ($) for Phase IV in selected CEE countries, 2009

Figure 5.55: Average per patient investigator fee ($) for Phase IV in selected CEE countries, by therapeutic area, 2009

Figure 5.56: Average per patient investigator fee ($) for Phase IV in selected Latin American countries, 2009

Figure 5.57: Average per patient investigator fee ($) for Phase IV in selected Latin American countries, by therapeutic area, 2009

Figure 5.58: Average per patient investigator fee ($) for Phase IV in selected Asian countries, 2009

Figure 5.59: Average per patient investigator fee ($) for Phase IV in selected Asian countries, by therapeutic area, 2009

Figure 5.60: Average per patient investigator fee ($) for Phase IV by selected countries, 2009

Figure 5.61: Average per patient investigator fee ($) for Phase IV by therapeutic area, in selected countries, 2009

Figure 5.62: Average per patient investigator fee ($) for Phase I-IV by selected geographic regions, 2009

Figure 5.63: Average per patient investigator fee ($) for Phase IV by therapeutic area in selected countries, 2009

Figure 6.64: Comparison of average pharmacy fees in selected geographic regions ($), 2009 202

Figure 7.65: Multinational CRO average salaries per international employee in the principal Western European countries

Figure 7.66: CRO average salaries by employee type in the principal Central and Eastern European countries $000s/per Annum, 2009

Figure 7.67: CRO average salaries by employee type in the principal Latin American countries $000s/per Annum, 2009

Figure 7.68: CRO average salaries by employee type in the principal Asian countries $000s/per Annum, 2009

List of Tables

Table 3.1: Fees for authorization for Phase I clinical trial (ISS) Italy

Table 3.2: Fees for authorization of a clinical trial (UK)

Table 3.3: Fees for substantial amendments of a clinical trial (UK)

Table 3.4: Fees for authorization for clinical trials: Russia

Table 3.5: Guidelines and forms for authorization of clinical trails Czech Republic

Table 3.6: Documents required for initial application Czech Republic

Table 3.7: Documents required initial application Czech Republic

Table 3.8: Fees for authorization for clinical trials: Poland

Table 3.9: Application fees according to the drug and cosmetics act India

Table 4.10: Ethical committee fees for clinical trials: Russia

Table 5.11: Principal clinical trial cost centers

Table 6.12: Laboratory test fees United States versus Europe ($) (central laboratories)

Table 6.13: Laboratory test fees United States versus the Central and Eastern European countries ($), 2009

Table 6.14: Laboratory test fees United States compared to principal Latin American countries ($), 2009

Table 6.15: Laboratory test fees United States Compared to Principle Asian countries ($), 2009

Table 6.16: Laboratory test shipping temperate considerations in the mature and emerging clinical trial markets

Table 6.17: Pharmacy fees in the principal Western European countries ($), 2009

Table 6.18: Pharmacy fees in the principal Central and Eastern European countries ($)

Table 6.19: Pharmacy fees in the principal Latin American countries ($)

Table 6.20: Pharmacy fees in the principal Asian countries ($)

Table 6.21: Regulatory requirements: clinical trial liability insurance Western, Central and Eastern Europe

Table 6.22: Regulatory Requirements: Clinical Trial Liability Insurance Asia, Latin America and the United States

Table 7.23: Multinational CRO average salaries Per International Employee in the Principle Western European countries $000s/per annum

Table 7.24: CRO average salaries by employee type in the principal Central and Eastern European countries $000s/per Annum

Table 7.25: CRO average salaries by employee type in the principal Latin American countries $000s/per Annum, 2009

Table 7.26: CRO average salaries by employee type in the principal Asian countries $000s/per Annum, 2009

Abstract

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