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市場調查報告書
新興醫療實驗據點（拉丁美洲）：市場動向及變動醫療領域及法規限制環境
Emerging Clinical Trial Locations -Latin America: Market dynamics and the changing healthcare and regulatory environment
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新興醫療實驗據點（拉丁美洲）：市場動向及變動醫療領域及法規限制環境 是由出版商Business Insights在2009年06月所出版的。
這份英文市場調查報告書包含144 pages 價格從美金3835起跳。
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
Latin America.
Table of Contents
Executive summary
- Introduction
- Conducting clinical trials in emerging markets
- Latin America
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 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 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: Population projection (' 000s) - Brazil, 2000-2050
- Figure 3.15: Population projection (thousands) - Argentina, 2000-2050
- Figure 3.16: Population projection (thousands) - Mexico, 2000-2050
- Figure 3.17: Forecast growth ($bn) Latin America pharmaceutical market,
2008-2013
- Figure 3.18: Latin America pharmaceutical market 2008
- Figure 3.19: No. of clinical trials in Latin America, 2000-2008
- Figure 3.20: Clinical trials by phase in Latin America (number of trials),
2008
- Figure 3.21: Registered Research Ethics Committees (REC) by Region -
Brazil 2008
- Figure 3.22: Regulation of clinical trials in Latin America 2007
- Figure 3.23: Regulatory flowchart - Brazil
- Figure 3.24: Regulatory flowchart - Argentina
- Figure 3.25: Regulatory flowchart - Mexico
List of Tables
- Table 2.1: Demographics of selected emerging markets, 2007
- Table 2.2: Ethical principles & their application for research
- Table 3.3: Ten leading causes of death, Argentina, 2003
- Table 3.4: Ten leading causes of death, Mexico, 2004 (compared to rate in
2000)
- Table 3.5: Top 10 pharma companies ($m) in Brazil, Argentina, and Mexico,
2008
- Table 3.6: Major CROs operating in Latin America, 2009
- Table 3.7: Ten leading causes of death in Brazil, 2003
- Table 3.8: Snapshot of hospitals in Argentina, 2007
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