Report: Emerging Clinical Trial Locations - China: Market dynamics and the changing healthcare and regulatory environment TOC

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

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

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

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

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

Emerging Clinical Trial Locations - China: Market dynamics and the changing healthcare and regulatory environment