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

Business Insights
January 1, 2010
250 Pages - SKU: RET2578686

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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.

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

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

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