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Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
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Emerging Clinical Trial Locations ' China: Market dynamics and the changing healthcare and regulatory environment

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.

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

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Emerging Clinical Trial Locations China: Market dynamics and thechanging healthcare and regulatory environmentPublished on June 2009 Report SummaryOver the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by avariety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that thecurrent business models have become both economically unsustainable and operationally unsuited to act quickly enough to producethe types of innovative treatments that will be demanded by global markets. Major issues confronting both the pharmaceutical andbiotechnology market are: the requirement to reduce the escalating costs and risks associated with drug development; and reduceclinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. Thebiopharmaceutical industry has recognized the opportunities and advantages that exist by conducting clinical trials in what arereferred to as the emerging markets. This report identifies market dynamics and key regulatory changes, and analyzes theimplications and factors which need to be taken into consideration when conducting clinical trials in China. Table of ContentTable of ContentsEmerging clinical trial locations - ChinaExecutive summary 10Introduction 10Conducting clinical trials in emerging markets 11China 12Chapter 1 Introduction 14Summary 14Introduction 15Generic competition 15Intellectual property protection 15Managing regulatory compliance 17Cost containment and government funding restrictions 18Obtaining and maintaining competitive advantage 18Recruitment and retention of a skilled workforce 19Improvement to R&D productivity 20High risks and costs associated with drug development 20Escalating costs of clinical trials 20Global increase in the number of clinical trials conducted 23Longer R&D timelines 24Increased attrition rates during R&D 26Clinical trial study design and planning 27Emerging Clinical Trial Locations China: Market dynamics and the changing healthcare and regulatory environment Page 1/7
  2. 2. Find Industry reports, Company profilesReportLinker and Market StatisticsClinical trial study design 27Clinical trial study protocol 28Clinical trial sponsors 28Identifying and recruiting patients 28Role of CROs 29Information technology and new technology platforms 29Drivers of development 30Advantages associated with EDC 30Advantages of electronic Clinical Trial Management Systems(CTMS) 30Cost saving 31Issues and challenges 31Electronic records and signatures 31Integration and linkage of electronic systems 32Security and confidentiality of patient data 32Chapter 2 Conducting clinical trials in emerging markets 36Summary 36Introduction 37Market drivers 39Rapid recruitment of patients and clinical trial investigators 39Significant cost benefits 41Improving transparency and efficiency of regulatory systems 42Harmonization and standardization of regulatory requirements 43Expansion of CROs 44Conducive hospital infrastructure and healthcare systems 46Enhanced clinical site effectiveness 47Future commercial value 49Key barriers 50Concerns over the clinical trial transparency 50Publication bias 51Selective reporting 52Duplicate publication 53Conflict of interest 53Availability of demographic and epidemiology data 53Critical components concerning capacity building 53Assimilation of individual national regulations and guidelines 56United States 56Japan 57European Union 58Language translation 59Ethical challenges 60Health needs of the population under study 60Respect for potential and enrolled subjects 61Ethical oversight 61Lack of review by institutional review board (IRB) 61Absence of informed consent 62Scientific validity 63Inadequate protection of intellectual property 64Clinical trial logistics 64Import licenses and applications 64Emerging Clinical Trial Locations China: Market dynamics and the changing healthcare and regulatory environment Page 2/7
  3. 3. Find Industry reports, Company profilesReportLinker and Market StatisticsCustoms regulations 65Storage, handling and distribution 66Selecting an appropriate CRO 67Patient enrolment 70Site selection 70Site activation 71Patient recruitment 71Chapter 3 China 74Summary 74Introduction 75Geographic 75Political 75Economic 76Market dynamics 78Vital statistics 78Population statistics 78Epidemiology and prevalence of major disease 78Pharmaceutical market 80CRO market 82Overseas CROs 84Joint venture companies 85Local CROs 86Clinical trial market 88Market drivers 89Rapid patient recruitment from large pool of treatment naïve patients 89Well-trained and motivated clinical trial investigators 89Major cost savings 89Increasing importance of the pharmaceutical market in China 90US government opens FDA offices in China 91Financial support and incentives from the Chinese government 92Creation of the Chinese Clinical Trial Register (CHiCTR) 92Key barriers 94Cultural and linguistic 94Delays to application and gaining approval 94Due diligence required to ensure intellectual property protection 95Issues over importation and importation licenses 95Monitor compliance of SFDA GCP with ICH GCP 95Healthcare 96Healthcare system 96Overview 96Healthcare reforms 98Healthcare institutions 99Hospital resources 100Regulation 102Regulatory authorities 102State Food and Drug Administration (SFDA) 102Department of drug registration 103Clinical trial regulation 104Application and approval of the new drug clinical trial study 104Registration approval for the manufacture of the new drug for market 105Emerging Clinical Trial Locations China: Market dynamics and the changing healthcare and regulatory environment Page 3/7
  4. 4. Find Industry reports, Company profilesReportLinker and Market StatisticsLegislation 108Patent Law and WTO TRIPS 108Drug Administration Law of the Peoples Republic of China 111Outlook 115Chapter 4 Appendix 118Introduction to clinical trials 118Clinical trial phases 118Phase I 118Phase II 118Phase III 119Phase IV 119What is a clinical trial 119Clinical trials of pharmaceutical agents 120Types of clinical trial 121Pilot studies 121Proof of concept (PoC) trials 121Randomized clinical studies 121Controlled clinical trials 121Parallel studies 122Parallel group trials 122Cohort studies 122Case control studies 122Role of the chief investigator 123Clinical trial protocol and procedure 123Determination of the clinical trial size 124Role of the coordinating centre and trials unit 124Role of the trial coordinator 124The trial principle investigator 125Forms and data management 125Trial data analysis and evaluation 126Ethical issues and conduct of clinical trial research 126Interpretation and publication of clinical trial results 127Principle regulatory agencies 127The European Agency for the Evaluation of Medicinal Products (EMEA) 127The United States Food and Drug Administration (US FDA) 127Japanese Ministry of Health, Labor and Welfare (MHLW) 128Methodology statement 129Primary Data and Information Gathering 129Secondary data and information gathering 130Definitions of Product-Life Cycle stages 132Glossary of abbreviations and acronyms 133List of FiguresFigure 1.1: Key issues facing Pharma and Biotech companies 16Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008 21Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e 22Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e 22Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e 23Figure 2.6: Comparison of locations across selected countries 38Emerging Clinical Trial Locations China: Market dynamics and the changing healthcare and regulatory environment Page 4/7
  5. 5. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 2.7: Korean Food and Drug Administration (KFDA) Approval Process 43Figure 2.8: CRO Segment Leaders 45Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries 48Figure 2.10: Fewer ineffective sites in the emerging countries 48Figure 2.11: Critical components for capacity building/conducting clinical trials 54Figure 2.12: Assessing clinical trial location feasibility 55Figure 2.13: CRO selection criteria 70Figure 3.14: Administrative divisions of the Peoples Republic of China 77Figure 3.15: Pharma market in China ($), 2007-2008 81Figure 3.16: CRO market in China (US$), 2007-2012 83Figure 3.17: Cost of clinical trials (%) in China vs western countries 90Figure 3.18: The Chinese Healthcare System 97Figure 3.19: NRCMCS medical cover cost and benefits in China 99Figure 3.20: Current drug approval and evaluation process in China 105Figure 3.21: Application and approval procedure for clinical trials China 107Figure 3.22: Location of accredited sites for clinical trials in China 113List of TablesTable 2.1: Demographics of selected emerging markets, 2007 40Table 2.2: Ethical principles & their application for research 62Table 3.3: China Population Projections (m people), 1950-2050 79Table 3.4: Ten leading causes of death in China, 2002 79Table 3.5: Prevalence of major cancers in China, 2007 80Table 3.6: Top 10 pharmaceutical companies ($m) in China, 2008 82Table 3.7: Major multinational CROs operating in China 84Table 3.8: Local Chinese owned CROs 87Table 3.9: Number of healthcare institutions according to ownership China 100Table 3.10: Total number of hospitals by ranking China 101Table 3.11: Chinese government agencies responsible for drug regulation 102Emerging Clinical Trial Locations China: Market dynamics and the changing healthcare and regulatory environment Page 5/7
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