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市場調查報告書
新興醫療實驗地點（中國）：市場力學及變動醫療・法規限制環境
Emerging Clinical Trial Locations - China: Market dynamics and the changing healthcare and regulatory environment
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新興醫療實驗地點（中國）：市場力學及變動醫療・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143 pages 價格從美金3835起跳。
本報告書內容包括：中國醫療實驗的實施環境調查分析、中國的地理・政治・經濟背景、藥品・CRO・醫療實驗市場動向、醫療制度、法規限制環境、中國的市場機會及課題等。內容綱要摘記如下：
實施概要
第1章 介紹
- 摘要
- 介紹
- 醫療實驗設計及計畫
- 醫療實驗贊助商
- 患者選擇及採用
- CRO的角色
- 資訊技術・新技術平台
第2章 新興市場的醫療實驗實施
- 摘要
- 介紹
- 市場促進因素
- 迅速採用患者及調查人員
- 成本優勢
- 改善透明度及法規限制制度的效率
- 鬆綁法規限制條件及標準化
- CRO擴大發展、等
- 主要障礙
- 透明度的顧慮
- 人口統計資料及流行病學資料的供給性
- 倫理課題
- 智慧財產權保護的課題
- 選擇適當的CRO的課題、等
第3章 中國市場
- 摘要
- 介紹
- 市場力學
- 市場促進因素
- 主要障礙
- 醫療市場
- 法規限制
- 未來預測
第4章 附錄
圖表
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
China.
Table of Contents
Executive summary
- Introduction
- Conducting clinical trials in emerging markets
- China
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 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 for market
- Legislation
- Patent Law and WTO TRIPS
- Drug Administration Law of the People' s Republic of China
- 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: Administrative divisions of the People' s Republic of China
- Figure 3.15: Pharma market in China ($), 2007-2008
- Figure 3.16: CRO market in China (US$), 2007-2012
- Figure 3.17: Cost of clinical trials (%) in China vs western countries
- Figure 3.18: The Chinese Healthcare System
- Figure 3.19: NRCMCS medical cover cost and benefits in China
- Figure 3.20: Current drug approval and evaluation process in China
- Figure 3.21: Application and approval procedure for clinical trials China
- Figure 3.22: Location of accredited sites for clinical trials in China
List of Tables
- Table 2.1: Demographics of selected emerging markets, 2007
- Table 2.2: Ethical principles & their application for research
- Table 3.3: China Population Projections (m people), 1950-2050
- Table 3.4: Ten leading causes of death in China, 2002
- Table 3.5: Prevalence of major cancers in China, 2007
- Table 3.6: Top 10 pharmaceutical companies ($m) in China, 2008
- Table 3.7: Major multinational CROs operating in China
- Table 3.8: Local Chinese owned CROs
- Table 3.9: Number of healthcare institutions according to ownership China
- Table 3.10: Total number of hospitals by ranking China
- Table 3.11: Chinese government agencies responsible for drug regulation
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