Reportlinker Adds Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
NEW YORK, Feb. 16 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
Over the last decade both the pharmaceutical and biopharmaceutical companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have now become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets. One of the major issues confronting both the pharmaceutical and biopharmaceutical industries is the requirement to a) reduce the escalating costs and risks associated with drug development and b) reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. The pharmaceutical and biopharmaceutical industry have recognised the opportunities and advantages that exist by conducting clinical trials in what is referred to as the emerging markets. These markets offer significant advantages to the traditional clinical trial settings i.e. rapid recruitment of treatment naive patients from large patient pool, cost benefits associated with lower labour and service fees, improved transparency and compliance with international regulations, expansion of CROs, improved hospital and facilities infrastructure and huge future commercial value in emerging trial markets. This report analyses the background to these markets including a review of the relevant legislation and regulations governing the control of clinical trials in the key emerging markets as well as analysing the implications and factors which need to be taken into consideration when conducting clinical trials in these markets.
Table of Contents
Investigating clinical trial costs: Comparative analysis of trial cost components in key geographies
Executive summary 14
Introduction and background to clinical trials 14
Financial considerations & planning of clinical trials 15
Cost analysis of clinical trial authorization by responsible authorities 16
Cost analysis of clinical trial review by ethics committees 18
Review and cost analysis of investigator fees by selected country 20
Review and cost analysis of laboratory fees, pharmacy costs and clinical
trial liability insurance by selected country 21
Review and cost analysis of CRO salaries by selected country 23
Chapter 1 Introduction and background to clinical trials 26
Summary 26
Introduction and background to pharmaceutical industry issues 27
High risks and costs associated with drug development 28
Escalating costs associated with clinical trials 28
Global increase in the number of clinical trials conducted 33
Longer R&D timelines 34
Increased attrition rates during pharmaceutical research and development 36
Improvement to R&D productivity and reducing time to market for next generation drugs 37
New business models for the pharmaceutical industry 37
Introduction to clinical trials and clinical trial studies 40
What is a clinical trial 40
Clinical trials of pharmaceutical agents 40
Types of clinical trial 41
Drug development process 44
Drug discovery 44
Preclinical development 44
Clinical trial phases 45
The role of the chief investigator 46
Clinical trial protocol and procedure 46
Determination of the clinical trial size 47
The role of the co-coordinating centre and trials unit 47
The role of the trial co-coordinator 47
The trial principal investigator 48
Forms and data management 48
Trial data analysis and evaluation 49
Ethical issues and conduct of clinical trail research 49
Interpretation and publication of clinical trial results 50
Clinical trial study design and planning 50
Clinical trial study design 50
Clinical trial study protocol 51
Clinical trial sponsors 51
Identifying and recruiting patients for clinical trials 52
Contract research organizations (CRO) 52
What are CROs 52
The role of CROs 52
Principle pharmaceutical and pharmaceutical regulatory agencies 53
The European Agency for the Evaluation of Medicinal Products (EMEA) 53
The United States Food and Drug Administration (US FDA) 53
Japanese Ministry of Health, Labor and Welfare (MHLW) 54
Chapter 2 Financial considerations and planning of clinical trials 56
Summary 56
Introduction 57
Key variables to consider for resource budgeting and allocation 59
Elements of successful budgeting 60
Development of the clinical trial protocol 61
Design and planning the clinical trial 66
Clinical trial design 66
Clinical trial planning 67
Multi-purpose studies 67
Clinical trial budget development process and cost analysis 68
Direct costs 71
Commonly overlooked clinical trial budget items 72
Chapter 3 Cost analysis of clinical trial authorization by responsible authorities 76
Summary 76
Introduction 78
Authorization process for clinical trials 79
European authorization process for clinical trials 79
Comparison of fees incurred: in the principal Western European countries 81
France 81
Germany 81
Italy 82
Spain 84
United Kingdom 85
Selected other Western European countries 86
Denmark 86
Sweden 86
Finland 87
Norway 87
The Netherlands 87
Comparison of fees incurred in the principal Central and Eastern
European countries 88
Russia 88
Czech Republic 90
Poland 93
Hungary 94
Comparison of fees incurred in the principal Latin American countries 95
Argentina 95
Brazil 96
Mexico 98
Comparison of fees incurred in the principal Asian countries 100
India 100
Application and authorization process fees: India 101
China 103
Authorization process for clinical trials: United States 105
Chapter 4 Cost analysis of clinical trial review by ethics committees 108
Summary 108
Introduction 109
Fees for assessment of clinical trial applications by Research Ethics
Committees (ECS) in the principal Western European countries 110
France 110
Germany 110
Italy 111
Spain 112
United Kingdom 113
Selected other Western European countries 113
Denmark 113
Sweden 114
Finland 115
Norway 116
The Netherlands 116
Fees for assessment of clinical trial applications by research ethics committees in the principal Central and Eastern European countries 117
Russia 117
Czech Republic 119
Poland 120
Hungary 121
Fees for assessment of clinical trial applications by research ethics committees in the principal Latin American countries 122
Argentina 122
Brazil 123
Mexico 125
Fees for assessment of clinical trial applications by research ethics committees in the principal Asian countries 125
India 125
China 126
Fees for assessment of clinical trial applications by research ethics committees (RECs) in the United States 127
Chapter 5 Review and cost analysis of investigator fees by selected country 130
Summary 130
Introduction 131
Analysis of investigator fees: Phase I 135
Review and cost analysis of investigator fees in the principal Western European countries (Phase I) 135
Review and cost analysis of investigator fees in selected Central and Eastern European countries (Phase I) 137
Review and cost analysis of investigator fees in the selected Latin American countries (Phase I) 139
Review and cost analysis of investigator fees in the selected Asian countries (Phase I) 141
Review and cost analysis of investigator fees in the United States for Phase I and comparison with other selected countries 144
Analysis of investigator fees: Phase II 146
Review and cost analysis of investigator fees in the principal Western European countries (Phase II) 146
Review and cost analysis of investigator fees in the selected Central and Eastern European countries (Phase II) 147
Review and cost analysis of investigator fees in the selected Latin American countries (Phase II) 149
Review and cost analysis of investigator fees in selected Asian countries (Phase II) 152
Review and cost analysis of investigator fees in the United States for Phase II and comparison with other selected countries 155
Analysis of investigator fees: Phase III 157
Review and cost analysis of investigator fees in the selected Central and Eastern European countries (Phase III) 159
Review and cost analysis of investigator fees in the selected Latin American countries (Phase III) 161
Review and cost analysis of investigator fees in selected Asian countries (Phase III) 163
Review and cost analysis of investigator fees in the United States for Phase III and comparison with other selected countries 165
Analysis of investigator fees: Phase IV 167
Review and cost analysis of investigator fees in the selected Central and Eastern European countries (Phase IV) 169
Review and cost analysis of investigator fees in the selected Latin American countries (Phase IV) 171
Review and cost analysis of investigator fees in selected Asian countries (Phase IV) 173
Review and cost analysis of investigator fees in the United States for Phase IV and comparison with other selected countries 175
Summary of investigator fees analysis: Phase I-IV, by therapeutic area and by selected geographic regions 177
Chapter 6 Review and cost analysis of laboratory fees, pharmacy costs and clinical trial liability insurance by selected country 183
Summary 183
Review and cost analysis of laboratory fees by selected country 185
Introduction 185
Laboratory fees: key variables 187
Review and cost analysis of laboratory fees in the principal Western European countries versus the United States 190
Review and cost analysis of laboratory fees in the principal Central and Eastern European countries versus the United States 191
Review and cost analysis of laboratory fees in the principal Latin American countries versus the United States 192
Review and cost analysis of laboratory fees in the principal Asian countries versus the United States 194
Other laboratory test costs and budget preparation fees 195
Review and cost analysis of pharmacy costs by selected country 197
Introduction 197
Comparison of pharmacy costs in the selected countries 197
Comparison of the average pharmacy fees in the selected geographic regions 202
Review and cost analysis of patient clinical trial liability insurance by selected country 203
Introduction 203
Comparison of clinical trial liability insurance requirements in the principal Western European countries 204
Comparison of clinical trial liability insurance requirements in the principal Central and Eastern European countries 206
Comparison of clinical trial liability insurance requirements in the principal Latin American countries 208
Comparison of clinical trial liability insurance requirements in the principal Asian countries 209
Clinical trial liability insurance requirements in the United States 210
Comparison of clinical trial liability insurance 211
Chapter 7 Review and cost analysis of CRO salaries by selected country 214
Summary 214
Evolution of the industry 215
Structure of CRO operating expenses reporting systems 216
Direct expenses 216
Research and development 217
Selling, general and administrative 217
Comparison of CRO salaries in the principal Western European countries 219
Comparison of CRO salaries in the principal Central and Eastern European countries 223
Comparison of CRO salaries in the principal Latin American countries 226
Comparison of CRO salaries in the principal Asian countries 229
Chapter 8 Appendix 234
Methodology statement 234
Primary data and information gathering 234
Secondary data and information gathering 235
Market share analysis and market forecast predictions 237
Definitions of product lifecycle stages 237
Glossary of abbreviations and acronyms 238
List of Figures
Figure 1.1: Key issues facing pharma and biotech companies 28
Figure 1.2: New Drug Approvals and R&D spending 30
Figure 1.3: Change in investment level by development phase between 2001 and 2007 31
Figure 1.4: Pharmaceutical research and development expenditure (2004-2009e) 32
Figure 1.5: Biotech R&D spending ($bn), 2004-2009e 32
Figure 1.6: Change in investment level by development phase, 2001-07 39
Figure 2.7: Overall clinical trial costs in various countries compared to the United States 58
Figure 2.8: Protocol target population checklist 61
Figure 2.9: Protocol feasibility checklist 62
Figure 2.10: Protocol budgetary considerations 63
Figure 2.11: Review and approval process for new clinical trials (Europe) 64
Figure 2.12: General review and approval process for new clinical trials (USA) 65
Figure 2.13: Budget process 69
Figure 3.14: Procedure for starting a clinical trial in the EU 80
Figure 3.15: Regulatory flowchart - Argentina 96
Figure 3.16: Regulatory flowchart - Brazil 97
Figure 3.17: Regulatory flowchart - Mexico 100
Figure 3.18: Application and approval procedure for clinical trials in China 104
Figure 4.19: Registered research ethics committees (REC) by Region – Brazil 2008 124
Figure 5.20: Key factors influencing the investigator fees 133
Figure 5.21: Relative cost per patient (CPP) by therapeutic area for investigators 134
Figure 5.22: Average per patient investigator fee ($) for Phase I by selected Western European countries, 2009 135
Figure 5.23: Average per patient investigator fee ($) for Phase I by therapeutic area, Western Europe, 2009 136
Figure 5.24: Average per patient investigator fee ($) for Phase I by selected Central and Eastern European countries, 2009 137
Figure 5.25: Average per patient investigator fee ($) for Phase I by therapeutic area in select CEE countries 2009 138
Figure 5.26: Average per patient investigator fee ($) for Phase I by selected Latin American countries, 2009 139
Figure 5.27: Average per patient investigator fee ($) for Phase I by therapeutic area in select Latin American countries, 2009 140
Figure 5.28: Average per patient investigator fee ($) for Phase I by selected Asian countries, 2009 141
Figure 5.29: Average per patient investigator fee ($) for Phase I by therapeutic area in select Asian countries, 2009 142
Figure 5.30: Average per patient investigator fee ($) for Phase I by selected countries, 2009 144
Figure 5.31: Average per patient investigator fee ($) for Phase I by therapeutic area, selected countries, 2009 145
Figure 5.32: Average per patient investigator fee ($) for Phase II by selected Western European countries, 2009 146
Figure 5.33: Average per patient investigator fee ($) for Phase II by therapeutic are in selected Western European countries, 2009 147
Figure 5.34: Average per patient investigator fee ($) for Phase II by selected CEE countries, 2009 148
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Figure 5.35: Average per patient investigator fee ($) for Phase II by therapeutic area in selected CEE countries, 2009 149
Figure 5.36: Average per patient investigator fee ($) for Phase II by selected Latin American countries, 2009 150
Figure 5.37: Average per patient investigator fee ($) for Phase II by therapeutic area in select Latin American countries, 2009 151
Figure 5.38: Average per patient investigator fee ($) for Phase II in selected Asian, 2009 152
Figure 5.39: Average per patient investigator fee ($) for Phase II by therapeutic area in select Asian countries, 2009 153
Figure 5.40: Average per patient investigator fee ($) for Phase II in selected countries, 2009 155
Figure 5.41: Average per patient investigator fee ($) for Phase II in selected therapeutic areas, 2009
156
Figure 5.42: Average per patient investigator fee ($) for Phase III in selected Western European countries, 2009 157
Figure 5.43: Average per patient investigator fee ($) for Phase III in selected Western European countries, by therapeutic area, 2009 158
Figure 5.44: Average per patient investigator fee ($) for Phase III in selected CEE countries, 2009 159
Figure 5.45: Average per patient investigator fee ($) for Phase III in selected CEE countries, by therapeutic area, 2009 160
Figure 5.46: Average per patient investigator fee ($) for Phase III in selected Latin American countries, 2009 161
Figure 5.47: Average per patient investigator fee ($) for Phase III in selected Latin American countries, by therapeutic area, 2009 162
Figure 5.48: Average per patient investigator fee ($) for Phase III in selected Asian countries, 2009 163
Figure 5.49: Average per patient investigator fee ($) for Phase III in selected Asian countries, by therapeutic area, 2009 164
Figure 5.50: Average per patient investigator fee ($) for Phase III by selected countries, 2009 165
Figure 5.51: Average per patient investigator fee ($) for Phase III by therapeutic area, in selected countries, 2009 166
Figure 5.52: Average per patient investigator fee ($) for Phase IV in selected Western European countries, 2009 167
Figure 5.53: Average per patient investigator fee ($) for Phase IV in selected Western European countries, by therapeutic area, 2009 168
Figure 5.54: Average per patient investigator fee ($) for Phase IV in selected CEE countries, 2009 169
Figure 5.55: Average per patient investigator fee ($) for Phase IV in selected CEE countries, by therapeutic area, 2009 170
Figure 5.56: Average per patient investigator fee ($) for Phase IV in selected Latin American countries, 2009 171
Figure 5.57: Average per patient investigator fee ($) for Phase IV in selected Latin American countries, by therapeutic area, 2009 172
Figure 5.58: Average per patient investigator fee ($) for Phase IV in selected Asian countries, 2009 173
Figure 5.59: Average per patient investigator fee ($) for Phase IV in selected Asian countries, by therapeutic area, 2009 174
Figure 5.60: Average per patient investigator fee ($) for Phase IV by selected countries, 2009 175
Figure 5.61: Average per patient investigator fee ($) for Phase IV by therapeutic area, in selected countries, 2009 176
Figure 5.62: Average per patient investigator fee ($) for Phase I-IV by selected geographic regions, 2009 177
Figure 5.63: Average per patient investigator fee ($) for Phase IV by therapeutic area in selected countries, 2009 178
Figure 6.64: Comparison of average pharmacy fees in selected geographic regions ($), 2009 202
Figure 7.65: Multinational CRO average salaries per international employee in the principal Western European countries 220
Figure 7.66: CRO average salaries by employee type in the principal Central and Eastern European countries $000s/per Annum, 2009 225
Figure 7.67: CRO average salaries by employee type in the principal Latin American countries $000s/per Annum, 2009 227
Figure 7.68: CRO average salaries by employee type in the principal Asian countries $000s/per Annum, 2009 230
List of Tables
Table 3.1: Fees for authorization for Phase I clinical trial (ISS) Italy 84
Table 3.2: Fees for authorization of a clinical trial (UK) 85
Table 3.3: Fees for substantial amendments of a clinical trial (UK) 86
Table 3.4: Fees for authorization for clinical trials: Russia 89
Table 3.5: Guidelines and forms for authorization of clinical trails Czech Republic 91
Table 3.6: Documents required for initial application Czech Republic 92
Table 3.7: Documents required initial application Czech Republic 93
Table 3.8: Fees for authorization for clinical trials: Poland 93
Table 3.9: Application fees according to the drug and cosmetics act India 103
Table 4.10: Ethical committee fees for clinical trials: Russia 119
Table 5.11: Principal clinical trial cost centers 132
Table 6.12: Laboratory test fees United States versus Europe ($) (central laboratories) 190
Table 6.13: Laboratory test fees United States versus the Central and Eastern European countries ($), 2009 191
Table 6.14: Laboratory test fees United States compared to principal Latin American countries ($), 2009 192
Table 6.15: Laboratory test fees United States Compared to Principle Asian countries ($), 2009 194
Table 6.16: Laboratory test shipping temperate considerations in the mature and emerging clinical trial markets 196
Table 6.17: Pharmacy fees in the principal Western European countries ($), 2009 198
Table 6.18: Pharmacy fees in the principal Central and Eastern European countries ($) 199
Table 6.19: Pharmacy fees in the principal Latin American countries ($) 200
Table 6.20: Pharmacy fees in the principal Asian countries ($) 201
Table 6.21: Regulatory requirements: clinical trial liability insurance Western, Central and Eastern Europe 207
Table 6.22: Regulatory Requirements: Clinical Trial Liability Insurance Asia, Latin America and the United States 209
Table 7.23: Multinational CRO average salaries Per International Employee in the Principle Western European countries $000s/per annum 221
Table 7.24: CRO average salaries by employee type in the principal Central and Eastern European countries $000s/per Annum 224
Table 7.25: CRO average salaries by employee type in the principal Latin American countries $000s/per Annum, 2009 227
Table 7.26: CRO average salaries by employee type in the principal Asian countries $000s/per Annum, 2009 229
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Pharmaceutical Industry: Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
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