Table of Contents
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 naive 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 - Czech Republic
- Hospital resources - Czech Republic
- Healthcare system - Poland
- Ministry of Health
- National health fund
- Territorial self-government administrations
- Hospital resources - Poland
- Healthcare system - Russian Federation
- Hospital resources - Russian Federation
- Regulation and legislation
- Regulatory authorities
- SUKL - Czech Republic
- NIL - Poland
- RZN - Russian Federation
- Clinical trial regulation
- Czech Republic
- Poland
- Russian Federation
- Legislation
- Poland removes tax block for clinical trials
- Decree no. 226/2008 on good clinical practices - Czech Republic
- Russia
- Outlook
Chapter 4 Appendix
- Introduction to clinical trials
- Clinical trial phases
- Phase I
- Phase II
- Phase III
- Phase IV
- What is a clinical trial
- Clinical trials of pharmaceutical agents
- Types of clinical trial
- Pilot studies
- Proof of concept (PoC) trials
- Randomized clinical studies
- Controlled clinical trials
- Parallel studies
- Parallel group trials
- Cohort studies
- Case control studies
- Role of the chief investigator
- Clinical trial protocol and procedure
- Determination of the clinical trial size
- Role of the coordinating centre and trials unit
- Role of the trial coordinator
- The trial principle investigator
- Forms and data management
- Trial data analysis and evaluation
- Ethical issues and conduct of clinical trial research
- Interpretation and publication of clinical trial results
- Principle 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)
- Methodology statement
- Primary Data and Information Gathering
- Secondary data and information gathering
- Definitions of Product-Life Cycle stages
- Glossary of abbreviations and acronyms
List of Figures
- Figure 1.1: Key issues facing Pharma and Biotech companies
- Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008
- Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e
- Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e
- Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e
- Figure 2.6: Comparison of locations across selected countries
- Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process
- Figure 2.8: CRO Segment Leaders
- Figure 2.9: Enhanced clinical site effectiveness (patients per site) in
the emerging countries
- Figure 2.10: Fewer ineffective sites in the emerging countries
- Figure 2.11: Critical components for capacity building/conducting clinical
trials
- Figure 2.12: Assessing clinical trial location feasibility
- Figure 2.13: CRO selection criteria
- Figure 3.14: Pharmaceutical market by selected Central and Eastern
European countries, 2007
- Figure 3.15: Clinical trials Europe
- Figure 3.16: Clinical trials by phase (no trials) in the Czech Republic,
2008
- Figure 3.17: Clinical trials market ($m) in Poland, 2007-2010
- Figure 3.18: Clinical trials by therapy area (%) in Russia, 2008
- Figure 3.19: Clinical trials by phase (%) in Russia, 2008
- Figure 3.20: FDA inspection deficiencies in Russian sites
List of Tables
- Table 2.1: Demographics of selected emerging markets, 2007
- Table 2.2: Ethical principles & their application for research
- Table 3.3: Central and Eastern Europe population projection (m people),
2009
- Table 3.4: Population statistics - Russia
- Table 3.5: Principle city population statistics - Russia, 2008
- Table 3.6: Estimated total deaths (thousands) by cause and by selected
country
- Table 3.7: Top 10 pharmaceutical companies ($m) in Russia, Poland and the
Czech Republic, 2008
- Table 3.8: Major CROs operating in Eastern Europe (including Poland and
Czech Republic), 2009
- Table 3.9: Top 10 Russian regions by no. of new investigative sites,
2006-2008
- Table 3.10: Snapshot of hospitals in the Czech Republic
- Table 3.11: Snapshot of hospitals in Poland
- Table 3.12: Contact details regulatory authorities in selected Central and
Eastern European countries
- Table 3.13: Fees for clinical trial application (€ ) in the Czech
Republic, April 2009
- Table 3.14: Guidelines and Forms for Clinical Trials Czech Republic
- Table 3.15: Checklist of documents for initial application in Czech
Republic
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