Emerging Clinical Trial Locations - Eastern Europe

Market Dynamics and The Changing Healthcare and Regulatory Environment

Publication Date	June 2009
Publisher	Business Insights
Product Type	Report
Pages	147
ISBN Number	not applicable
Product Code	RBI00324

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Summary

Over the last decade pharmaceutical and biotechnology 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 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. Major issues confronting both the pharmaceutical and biotechnology market are: the requirement to reduce the escalating costs and risks associated with drug development; and reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. The biopharmaceutical industry has recognized the opportunities and advantages that exist by conducting clinical trials in what are referred to as the emerging markets. This report identifies market dynamics and key regulatory changes, and analyzes the implications and factors which need to be taken into consideration when conducting clinical trials in Eastern Europe.

Content

Executive summary
- Introduction
- Conducting clinical trials in emerging markets
- Central and Eastern Europe
Chapter 1 Introduction
- Summary
- Introduction
- Generic competition
- Intellectual property protection
- Managing regulatory compliance
- Cost containment and government funding restrictions
- Obtaining and maintaining competitive advantage
- Recruitment and retention of a skilled workforce
- Improvement to R&D productivity
- High risks and costs associated with drug development
- Escalating costs of clinical trials
- Global increase in the number of clinical trials conducted
- Longer R&D timelines
- Increased attrition rates during R&D
- Clinical trial study design and planning
- Clinical trial study design
- Clinical trial study protocol
- Clinical trial sponsors
- Identifying and recruiting patients
- Role of CROs
- Information technology and new technology platforms
- Drivers of development
- Advantages associated with EDC
- Advantages of electronic Clinical Trial Management Systems
- (CTMS)
- Cost saving
- Issues and challenges
- Electronic records and signatures
- Integration and linkage of electronic systems
- Security and confidentiality of patient data
Chapter 2 Conducting clinical trials in emerging markets
- Summary
- Introduction
- Market drivers
- Rapid recruitment of patients and clinical trial investigators
- Significant cost benefits
- Improving transparency and efficiency of regulatory systems
- Harmonization and standardization of regulatory requirements
- Expansion of CROs
- Conducive hospital infrastructure and healthcare systems
- Enhanced clinical site effectiveness
- Future commercial value
- Key barriers
- Concerns over the clinical trial transparency
- Publication bias
- Selective reporting
- Duplicate publication
- Conflict of interest
- Availability of demographic and epidemiology data
- Critical components concerning capacity building
- Assimilation of individual national regulations and guidelines
- United States
- Japan
- European Union
- Language translation
- Ethical challenges
- Health needs of the population under study
- Respect for potential and enrolled subjects
- Ethical oversight
- Lack of review by institutional review board (IRB)
- Absence of informed consent
- Scientific validity
- Inadequate protection of intellectual property
- Clinical trial logistics
- Import licenses and applications
- Customs regulations
- Storage, handling and distribution
- Selecting an appropriate CRO
- Patient enrolment
- Site selection
- Site activation
- Patient recruitment
Chapter 3 Central and Eastern Europe
- Summary
- Introduction
- Geographic
- Czech Republic
- Poland
- Russian Federation
- Political
- Czech Republic
- Poland
- Russian Federation
- Economic
- Czech Republic
- Poland
- Russian Federation
- Market dynamics
- Vital statistics
- Population statistics
- Epidemiology and prevalence of major diseases
- Pharmaceutical market
- CRO market
- Czech Republic
- Poland
- Russian Federation
- Clinical trial market
- Czech Republic
- Poland
- Russian Federation
- Market drivers
- Large eligible treatment na??ve population who exhibit high retention rates
- Large pool of dedicated, well trained and motivated investigators
- Cost savings
- Centralized healthcare systems and well-developed referral systems
- Entry of Russian Federation into the World Trade Organization (WTO)
- Positive assessments by the US FDA (Poland)
- Key barriers
- Poor hospital infrastructure with inadequate medical equipment
- Cultural differences and issues
- Potential delays importing the study drug (Russia)
- Concerns and issues obtained from regulatory inspections by the FDA
- (Russia)
- Lack of clinical trial experience amongst hospital staff and hospital services
- Healthcare
- Healthcare system ??