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市場調查報告書
新興的醫療實驗地點：市場力學及變化的醫療・法規限制環境
Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment
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Abstract
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, China, Latin America and India.
Table of Contents
Executive summary
- Introduction
- Conducting clinical trials in emerging markets
- India
- China
- Latin America
- 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 India
- Summary
- Introduction
- Geographic
- Market dynamics
- Vital statistics
- Population statistics
- Epidemiology and prevalence of major disease
- Pharmaceutical market
- Biotechnology market
- CRO market
- Clinical trial market
- Geographic focus of the Indian clinical research industry
- Market drivers
- Population ethnicity and genetic diversity
- Large complement of trained medical specialists in India
- Significant cost savings
- Government incentives
- Creation of the Clinical Trials Registry - India (CTRI)
- Sophisticated logistics and clinical research infrastructure
- Comprehensive IT and IT enabled support (ITES) base
- Key barriers
- Ethical issues
- Lack of experienced investigators
- Inability to detect and monitor ADRs
- Bribery and corruption
- Healthcare
- Healthcare system
- National level
- State level
- Regional level
- District level
- Sub-divisional/Taluka level
- Community level
- Primary health centre (PHC) level
- Sub health centre (SHC) level
- Hospital resources
- Regulation and legislation
- Regulatory authorities
- The Ministry of Health and Family Welfare
- Central Drug Standard Control Organization (CDSCO)
- Drug Controller General of India (DCGI)
- Indian Council of Medical Research (ICMR)
- Clinical trial regulation
- Harmonization of the clinical trial approval process
- Legislation
- Patent law and WTO TRIPS
- Schedule Y Drugs and Cosmetics Act and Rule
- Summary of the recent regulatory and legislative changes
- Evolution of the regulatory environment
- Expected improved collaboration: DCGI with international agencies
- Anticipation of approval for early phase studies in India
- Registration and regulation of CROs in India
- Future reform and emphasis on improved pharmacovigilance in
- India
- India to implement an electronic management system
- Outlook
Chapter 4 China
- Summary
- Introduction
- Geographic
- Political
- Economic
- Market dynamics
- Vital statistics
- Population statistics
- Epidemiology and prevalence of major disease
- Pharmaceutical market
- CRO market
- Overseas CROs
- Joint venture companies
- Local CROs
- Clinical trial market
- Market drivers
- Rapid patient recruitment from large pool of treatment naive patients
- Well-trained and motivated clinical trial investigators
- Major cost savings
- Increasing importance of the pharmaceutical market in China
- US government opens FDA offices in China
- Financial support and incentives from the Chinese government
- Creation of the Chinese Clinical Trial Register (CHiCTR)
- Key barriers
- Cultural and linguistic
- Delays to application and gaining approval
- Due diligence required to ensure intellectual property protection
- Issues over importation and importation licenses
- Monitor compliance of SFDA GCP with ICH GCP
- Healthcare
- Healthcare system
- Overview
- Healthcare reforms
- Healthcare institutions
- Hospital resources
- Regulation
- Regulatory authorities
- State Food and Drug Administration (SFDA)
- Department of drug registration
- Clinical trial regulation
- Application and approval of the new drug clinical trial study
- Registration approval for the manufacture of the new drug
- market
- Legislation
- Patent Law and WTO TRIPS
- Drug Administration Law of the People' s Republic of China
- Outlook
Chapter 5 Latin America
- Summary
- Introduction
- Geographic
- Political
- Economic
- Market dynamics
- Vital statistics - Brazil
- Population statistics
- Epidemiology and prevalence of major disease
- Vital statistics - Argentina
- Population statistics
- Epidemiology and prevalence of major diseases
- Vital statistics - Mexico
- Population statistics
- Epidemiology and prevalence of major disease
- Pharmaceutical market
- CRO market
- Clinical trial market
- Market drivers
- Significant cost savings
- High concentration of population in urban centers
- High ethnic diversity
- High patient enrolment, compliance and retention rates
- A major growing Latin American pharmaceutical market
- Reverse seasons advantages
- Commonality of Spanish language
- Accessibility to medical professionals and clinical trial investigators
- National clinical trials register - Argentina
- Key barriers
- Concerns over intellectual property protection
- Inconsistent regulatory environment
- Cultural challenges and issues
- Healthcare
- Healthcare system- Brazil
- Hospital resources - Brazil
- Healthcare system - Argentina
- Hospital resources - Argentina
- Healthcare system - Mexico
- Hospital resources - Mexico
- Regulation and guidelines
- Regulatory authorities
- The Pan American Network for Drug Regulatory Harmonization
- (PANDRH)
- ANVISA - Brazil
- Brazilian Research Ethics Commission (CONEP)
- ANMAT - Argentina
- SSA - Mexico
- COFEPRIS - Mexico
- Clinical trial regulation
- Guidelines
- Good Clinical Practices: Document of the Americas
- The Buenos Aires Declaration on Ethics and Clinical Trials
- Import licenses for drugs in clinical trials - Mexico
- Outlook
Chapter 6 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
Appendix
- Introduction to clinical trials
- Clinical trial phases
- Phase I
- Phase II
- 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
- Index
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: GDP in India (%) by sector
- Figure 3.15: Projected growth of healthcare industry in India ($bn),
2008-2022
- Figure 3.16: Population projection (millions) in India, 2000-2020
- Figure 3.17: Pharma industry in India ($bn), 2007-2010
- Figure 3.18: Market share (%) between MNCs and local pharmaceutical
companies in India, 2003-2007
- Figure 3.19: Outsourced clinical trial market in India (US$), 2002-2010
- Figure 3.20: Clinical trials in India (by phase), 2009
- Figure 3.21: Types of disease and types of hospitals in India
- Figure 3.22: Cost of clinical trials (%) in India vs US
- Figure 3.23: Structure of healthcare system in India
- Figure 3.24: Current organogram of the Ministry of Health and Family
Welfare
- Figure 3.25: Proposed organogram of the Ministry of Health and Family
Welfare
- Figure 3.26: Approval categories of global clinical trials in India
- Figure 4.27: Administrative divisions of the People' s Republic of China
- Figure 4.28: Pharma market in China ($), 2007-2008
- Figure 4.29: CRO market in China (US$), 2007-2012
- Figure 4.30: Cost of clinical trials (%) in China vs western countries
- Figure 4.31: The Chinese Healthcare System
- Figure 4.32: NRCMCS medical cover cost and benefits in China
- Figure 4.33: Current drug approval and evaluation process in China
- Figure 4.34: Application and approval procedure for clinical trials China
- Figure 4.35: Location of accredited sites for clinical trials in China
- Figure 5.36: Population projection (' 000s) - Brazil, 2000-2050
- Figure 5.37: Population projection (thousands) - Argentina, 2000-2050
- Figure 5.38: Population projection (thousands) - Mexico, 2000-2050
- Figure 5.39: Forecast growth ($bn) Latin America pharmaceutical market,
2008-2013
- Figure 5.40: Latin America pharmaceutical market 2008
- Figure 5.41: No. of clinical trials in Latin America, 2000-2008
- Figure 5.42: Clinical trials by phase in Latin America (number of trials),
2008
- Figure 5.43: Registered Research Ethics Committees (REC) by Region -
Brazil 2008
- Figure 5.44: Regulation of clinical trials in Latin America 2007
- Figure 5.45: Regulatory flowchart - Brazil
- Figure 5.46: Regulatory flowchart - Argentina
- Figure 5.47: Regulatory flowchart - Mexico
- Figure 6.48: Pharmaceutical market by selected Central and Eastern
European countries, 2007
- Figure 6.49: Clinical trials Europe
- Figure 6.50: Clinical trials by phase (no trials) in the Czech Republic,
2008
- Figure 6.51: Clinical trials market ($m) in Poland, 2007-2010
- Figure 6.52: Clinical trials by therapy area (%) in Russia, 2008
- Figure 6.53: Clinical trials by phase (%) in Russia, 2008
- Figure 6.54: FDA inspection deficiencies in Russian sites
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