Investigating Clinical Trial Costs Comparative Analysis of Trial Cost Components in Key Geographies Table of Contents

Transcription

1 Investigating Clinical Trial Costs Comparative Analysis of Trial Cost Components in Key Geographies Table of Contents 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

2 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 center 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

3 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

4 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

5 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

6 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 andeastern 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

7 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

8 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

9 Figure 1.3: Change in investment level by development phase between 2001 and Figure 1.4: Pharmaceutical research and development expenditure ( e) 32 Figure 1.5: Biotech R&D spending ($bn), e 32 Figure 1.6: Change in investment level by development phase, Figure 2.7: Overall clinical trial costs in various countries compared to the United States 58 Figure 2.8: Protocol target population checklist 61 Figure 2.9: Protocol feasibility checklist 62 Figure 2.10: Protocol budgetary considerations 63 Figure 2.11: Review and approval process for new clinical trials (Europe) 64 Figure 2.12: General review and approval process for new clinical trials (USA) 65 Figure 2.13: Budget process 69 Figure 3.14: Procedure for starting a clinical trial in the EU 80 Figure 3.15: Regulatory flowchart - Argentina 96 Figure 3.16: Regulatory flowchart - Brazil 97 Figure 3.17: Regulatory flowchart - Mexico 100 Figure 3.18: Application and approval procedure for clinical trials in China 104 Figure 4.19: Registered research ethics committees (REC) by Region Brazil Figure 5.20: Key factors influencing the investigator fees 133 Figure 5.21: Relative cost per patient (CPP) by therapeutic area for investigators 134 Figure 5.22: Average per patient investigator fee ($) for Phase I by selected Western European countries, Figure 5.23: Average per patient investigator fee ($) for Phase I by therapeutic area, Western Europe, Figure 5.24: Average per patient investigator fee ($) for Phase I by selected Central and Eastern European countries, Figure 5.25: Average per patient investigator fee ($) for Phase I by therapeutic area in select CEE countries

10 Figure 5.26: Average per patient investigator fee ($) for Phase I by selected Latin American countries, Figure 5.27: Average per patient investigator fee ($) for Phase I by therapeutic area in select Latin American countries, Figure 5.28: Average per patient investigator fee ($) for Phase I by selected Asian countries, Figure 5.29: Average per patient investigator fee ($) for Phase I by therapeutic area in select Asian countries, Figure 5.30: Average per patient investigator fee ($) for Phase I by selected countries, Figure 5.31: Average per patient investigator fee ($) for Phase I by therapeutic area, selected countries, Figure 5.32: Average per patient investigator fee ($) for Phase II by selected Western European countries, Figure 5.33: Average per patient investigator fee ($) for Phase II by therapeutic are in selected Western European countries, Figure 5.34: Average per patient investigator fee ($) for Phase II by selected CEE countries, xi Figure 5.35: Average per patient investigator fee ($) for Phase II by therapeutic area in selected CEE countries, Figure 5.36: Average per patient investigator fee ($) for Phase II by selected Latin American countries, Figure 5.37: Average per patient investigator fee ($) for Phase II by therapeutic area in select Latin American countries, Figure 5.38: Average per patient investigator fee ($) for Phase II in selected Asian, Figure 5.39: Average per patient investigator fee ($) for Phase II by therapeutic area in select Asian countries, Figure 5.40: Average per patient investigator fee ($) for Phase II in selected countries, Figure 5.41: Average per patient investigator fee ($) for Phase II in selected therapeutic areas, 2009

11 156 Figure 5.42: Average per patient investigator fee ($) for Phase III in selected Western European countries, Figure 5.43: Average per patient investigator fee ($) for Phase III in selected Western European countries, by therapeutic area, Figure 5.44: Average per patient investigator fee ($) for Phase III in selected CEE countries, Figure 5.45: Average per patient investigator fee ($) for Phase III in selected CEE countries, by therapeutic area, Figure 5.46: Average per patient investigator fee ($) for Phase III in selected Latin American countries, Figure 5.47: Average per patient investigator fee ($) for Phase III in selected Latin American countries, by therapeutic area, Figure 5.48: Average per patient investigator fee ($) for Phase III in selected Asian countries, Figure 5.49: Average per patient investigator fee ($) for Phase III in selected Asian countries, by therapeutic area, Figure 5.50: Average per patient investigator fee ($) for Phase III by selected countries, Figure 5.51: Average per patient investigator fee ($) for Phase III by therapeutic area, in selected countries, Figure 5.52: Average per patient investigator fee ($) for Phase IV in selected Western European countries, Figure 5.53: Average per patient investigator fee ($) for Phase IV in selected Western European countries, by therapeutic area, Figure 5.54: Average per patient investigator fee ($) for Phase IV in selected CEE countries, Figure 5.55: Average per patient investigator fee ($) for Phase IV in selected CEE countries, by therapeutic area, Figure 5.56: Average per patient investigator fee ($) for Phase IV in selected Latin American countries,

12 Figure 5.57: Average per patient investigator fee ($) for Phase IV in selected Latin American countries, by therapeutic area, Figure 5.58: Average per patient investigator fee ($) for Phase IV in selected Asian countries, Figure 5.59: Average per patient investigator fee ($) for Phase IV in selected Asian countries, by therapeutic area, Figure 5.60: Average per patient investigator fee ($) for Phase IV by selected countries,

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