Table of Contents
Executive summary
- Introduction
- Conducting clinical trials in emerging markets
- India
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
- Political
- Economic
- 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 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: 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$), 2002-2010
- Figure 3.20: Clinical trials in India (by phase), 2009
- Figure 3.21: Types of disease and types of hospitals in India
- Figure 3.22: Cost of clinical trials (%) in India vs US
- Figure 3.23: Structure of healthcare system in India
- Figure 3.24: Current organogram of the Ministry of Health and Family
Welfare
- Figure 3.25: Proposed organogram of the Ministry of Health and Family
Welfare
- Figure 3.26: Approval categories of global clinical trials in India
List of Tables
- Table 2.1: Demographics of selected emerging markets, 2007
- Table 2.2: Ethical principles & their application for research
- Table 3.3: Statistical healthcare data India
- Table 3.4: Ten leading causes of death (%) in India, 2002
- Table 3.5: Diseases of the developed world in India
- Table 3.6: Top 10 pharmaceutical companies ($m) in India, 2008
- Table 3.7: Major biotechnology products in India and their companies
- Table 3.8: Major CROs operating in India
- Table 3.9: Major specialty hospital groups operating in Northern India
- Table 3.10: Regulatory authorities based in Northern India
- Table 3.11: Snapshot of hospitals in India
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