Post Marketing Clinical Research - REMS, the Latest Reformation due to Post Marketing Surveillance to Enhance Patient Compliance


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82pages

GBI Research

$ 3500

In Stock


GBI Research has released its latest report, Post Marketing Clinical Research - REMS, the Latest Reformation due to Post Marketing Surveillance to Enhance Patient Compliance that provides key data, information and analysis of the major trends and developments in post marketing clinical research. The report provides a comprehensive insight into key technological developments, new approaches towards risk mitigation. 

The report talks about the key regulations, drug classes that require REMS and case studies of drugs for which REMS is required. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Researchs team of industry experts.

Scope

The scope of the report includes - 

  • Key technological developments, new approaches and strategies to mitigiate drug safety risks
  • Preclinical outsourcing market forecast, 2010-2017.
  • Analysis of regulation in each of the top geographies in US, Europe and Japan
  • Key drivers and barriers that have a significant impact on the industry

Reasons to buy

The report will enhance your decision making capability. It will allow you to - 

  • Evaluate the effectiveness of REMS against various classes of drugs that have a poor safety record
  • Understand best practices through case studies of REMS application in the industry
  • Develop effective strategies to maximize the advantages through the understanding of REMS
Table of Contents

1 Table of Contents

1 Table of Contents 4
1.1 List of Tables 5
1.2 List of Figures 6

2 Post Marketing Clinical Research Introduction 7
2.1 GBI Research Report Guidance 7

3 Post Marketing Clinical Research: Overview 8
3.1 Introduction 8
3.2 Objectives of Post Marketing Clinical Research 9
3.3 Establishing Safety through Clinical Trials 9
3.3.1 Pre-Approval Drug Safety 9
3.3.2 Post Marketing Drug Safety 10
3.4 Establishing Efficacy through Clinical Trials 10
3.5 Limitations of Phase I to Phase III Clinical Trials 11
3.6 Pharmaceutical Industry and Drug Safety Challenges 12
3.7 Post Marketing Clinical Research: an Unavoidable Necessity for the Pharmaceutical Industry 13
3.7.1 Phase IIIb Studies - Tool to Improve Revenues 13
3.7.2 Post Marketing Clinical Research-Promotes Public Health in Large Populations 13

4 Post Marketing Clinical Research: Objectives and Components 14
4.1 Introduction 14
4.2 Objectives of Post Marketing Clinical Research 14
4.2.1 Promoting Public Health 14
4.2.2 Market Development 18
4.3 Components of Post Marketing Clinical Research 21
4.3.1 Risk Evaluation and Mitigation Strategies (REMS) 22
4.3.2 Pharmacoeconomics 24
4.3.3 Pharmacoepidemiology 27
4.3.4 Pharmacovigilance 29

5 Post Marketing Clinical Research in Special Groups 35
5.1 Post Marketing Studies in Different Population Groups 35
5.1.1 Children 35
5.1.2 Elderly 37
5.1.3 Pregnancy 40
5.2 Post Marketing Studies in Different Therapy Areas 43
5.2.1 Oncology Therapeutics 43
5.2.2 Cardiovascular Therapeutics 44
5.2.3 Central Nervous System Therapeutics 45
5.2.4 Gene Therapy 45
5.3 Post Marketing Studies in Different Drug Classes 47
5.3.1 Orphan Drugs 47
5.3.2 Vaccines 48
5.3.3 Anti-HIV Drugs 50
5.3.4 Monoclonal Antibodies 51
5.3.5 Blood Products 53

6 Post Marketing Clinical Research - Regulatory Landscape 55
6.1 WHO Approach to Drug Safety 55
6.1.1 WHO Programme for International Drug Monitoring 55
6.1.2 Uppsala Monitoring Centre (UMC) 55
6.1.3 ICH-GCP and Post Marketing Clinical Research 56
6.2 Drug Safety Regulations in the US 57
6.2.1 FDA Amendment Act (FDAAA) 57
6.2.2 Implications of FDAAA on Pharmaceutical Industry 59
6.2.3 Role of FDA in Promoting Drug Safety 59
6.2.4 Adverse Event Reporting System 60
6.2.5 Drug Withdrawals from the US Market 62
6.3 Drug Safety Regulations in Europe 62
6.3.1 Incidences of Adverse Events in Europe 62
6.3.2 Safety Regulations in Europe 62
6.3.3 European Risk Management Strategy 63
6.3.4 EudraVigilance 63
6.3.5 Drug Safety Regulations in Europe and the US 64
6.4 Drug Safety Regulations in Japan 66
6.4.1 Pharmaceuticals and Medical Devices Agency 66
6.4.2 Good Post Marketing Surveillance Practice 66
6.4.3 Good Post Marketing Study Practice 67
6.4.4 Good Vigilance Practice 67
6.4.5 Adverse Drug Reaction Reporting System 68
6.4.6 Re-Examination and Re-Evaluation System 70
6.5 Drug Safety Regulations in Emerging Markets 71
6.5.1 Drug Safety Regulations in China 71
6.5.2 Drug Safety Regulations in Brazil 72
6.5.3 Drug Safety Regulations in Russia 73
6.5.4 Drug Safety Regulations in India 73

7 Post Marketing Clinical Research and Outsourcing 75
7.1 Introduction 75
7.2 Advantages of Outsourcing 75
7.3 Selection of Outsourcing Partners 76
7.4 Phase IV Outsourcing 76
7.5 Limitation of Outsourcing 77

8 Post Marketing Clinical Research - Appendix 78
8.1 Market Definitions 78
8.2 Abbreviations 78
8.3 Research Methodology 80
8.3.1 Coverage 80
8.3.2 Secondary Research 80
8.3.3 Primary Research 81
8.3.4 Expert Panel Validation 81
8.4 Contact Us 81
8.5 Disclaimer 81
8.6 Sources 82
Table 1: Post Marketing Clinical Research, Adverse Event Reports in the US (000), 2000-2009 61
Figure 1: Post Marketing Clinical Research, Safety Concept Through Clinical Research 10
Figure 2: Post Marketing Clinical Research, Limitations of Clinical Trials 11
Figure 3: Post Marketing Clinical Research, Assessment of Side Effects - Case Study 15
Figure 4: Post Marketing Clinical Research, Objectives of Post Marketing Clinical Research 20
Figure 5: Post Marketing Clinical Research, Components of Post Marketing Clinical Research 21
Figure 6: Post Marketing Clinical Research, Importance of REMS 23
Figure 7: Post Marketing Clinical Research, Perspective of Pharmacoeconomic Analysis 25
Figure 8: Post Marketing Clinical Research, Types of Pharmacoeconomic Research 26
Figure 9: Post Marketing Clinical Research, Epidemiology Study Designs 28
Figure 10: Post Marketing Clinical Research, Safety Signal Detection Methods 32
Figure 11: Post Marketing Clinical Research, Safety Signal Investigation and Evaluation 33
Figure 12: Post Marketing Clinical Research, Regulatory Provisions of Post Marketing Studies in Children 36
Figure 13: Post Marketing Clinical Research, Issues of Drug Safety in the Elderly - Case Study 39
Figure 14: Post Marketing Clinical Research, Drug Labeling and Pregnancy 41
Figure 15: Post Marketing Clinical Research, Issues of Drug Safety in Pregnant Women - Case Study 42
Figure 16: Post Marketing Clinical Research, Accelerated Approval of Oncology Drugs Gleevec Case Study 44
Figure 17: Post Marketing Clinical Research, Post Marketing Surveillance of Orphan Drugs Erbitux Case Study 48
Figure 18: Post Marketing Clinical Research, Post Marketing Surveillance of Vaccines Rotateq Case Study 49
Figure 19: Post Marketing Clinical Research, Drug Safety Monitoring of Anti-HIV Treatment Hivid Case Study 51
Figure 20: Post Marketing Clinical Research, Monoclonal Antibodies Mylotarg Case Study 52
Figure 21: Post Marketing Clinical Research, Monoclonal Antibodies Rituxan Case Study 53
Figure 22: Post Marketing Clinical Research, Functions of UMC 56
Figure 23: Post Marketing Clinical Research, Important Titles Under FDAAA, 2007 58
Figure 24: Post Marketing Clinical Research, Adverse Event Reports in the US (000), 2000-2009 61
Figure 25: Post Marketing Clinical Research, Post Marketing Surveillance System, Japan 70
Figure 26: Post Marketing Clinical Research, Limitations of Outsourcing 77