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.

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 pharmac