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

리서치사	Business Insights
발행일	2009년 06월	상품코드	92688
페이지 정보	149 pages
가격	US $ 3,835 ￦ 4,569,400 PDF by E-mail (Single User License) US $ 14,381 ￦ 17,134,900 PDF by E-mail (Global Site License)

한글목차
영문목차
관련자료

영문목차

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 India.

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