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