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2013 Late Phase Market Overview and Outlook

  • February 2013
  • -
  • Industry Standard Research
  • -
  • 109 pages

Late Phase studies are becoming more important to biopharmaceutical sponsors. As the line between clinical development and commercialization continues to blur, better decisions need to be made. In order to make better decisions, one needs better information.

This report provides some of that information: It gives sponsors the data to benchmark their internal Phase IV study characteristics such as enrollment and duration to anticipate future challenges and resourcing hurdles. And it gives service providers insight into what sponsors are buying, what they will buy, how they buy, where they will buy it, and how they select certain service providers.

Valuable for:

Clinical Operations • Late Phase • Medical Directors • Outsourcing • Project Managers • Medical Affairs

What you will learn in this report:

• 3-year examination of the industry’s Phase IV study characteristics (i.e. study type, size, length)
• Average per company spend on Late Phase studies
• Study conduct and outsourcing penetration across 16 Late Phase study types
• Sponsors’ organizational hierarchy for Late Phase decision-making
• Criteria sponsors use to select (and disqualify) clinical service providers by study type

How you can use this report:

For Sponsors: Benchmark your Late Phase study design and conduct against industry-wide, study specific trends to make more informed operational, resourcing, and outsourcing decisions.

For Service Providers: Drive operational and Late Phase sales strategies by understanding what studies are being conducted, which services sponsors are buying, what they will be buying, how they buy, where they will buy, and how they select clinical service providers.

Table Of Contents

2013 Late Phase Market Overview and Outlook
Table of Contents

Copyright and Usage Guidelines 6
Introduction 7
Methodology 8
Respondent Demographics and Qualifications 9
Company Characteristics 10
Organization Type 10
Organization size 10
Respondent Job Title 11
Respondent and Company HQ location 11
Functional Area Responsibility 12
Product Development Responsibility 13
Therapeutic Area Focus 14
Major sections 15
Study Findings 16
Growth and Decline in Study Conduct and Outsourcing 17
Late Phase Study Conduct and Outsourced Opportunity 18
Outsourcing Penetration - By Study Type 19
Average Per Company Spend - By Study Type 19
Section Summary 20
Three Year History of Phase IV Study Characteristics 21
Late Phase Funding Sources, Past 3 Years 22
Distribution of Late Phase Studies - Interventional vs Observational, Past 3 Years 23
Interventional Designs - Distribution of Study Purpose, Past 3 Years 24
Interventional Designs - Distribution of Intervention Model, Past 3 Years 24
Interventional Designs - Distribution of Masking Strategies, Past 3 Years 25
Interventional Designs - Subject Allocation Models, Past 3 Years 25
Interventional Designs - Classification of Endpoints, Past 3 Years 26
Observational Designs - Distribution of Study Models, Past 3 Years 27
Observational Designs - Distribution of Time Perspective, Past 3 Years 28
Average Phase IV Study Length By Sponsor Type, Past 3 Years 29
Average Phase IV Study Enrollment By Sponsor Type, Past 3 Years 30
Average Interventional and Observational Study Length, Past 3 Years 30
Average Interventional and Observational Study Enrollment, Past 3 Years 31
Phase IV Study Target Age Groups, Past 3 Years 31
Interventional Study Target Age Groups, Past 3 Years 32
Observational Study Target Age Groups, Past 3 Years 32
Section Summary 33
Service Provider Dynamics 34
Industry leadership 35
Industry Leadership 35
Service provider usage 36
Provider Usage 36
Preferred Service Provider 37
Delivery Satisfaction Drivers 38
Service Provider Satisfaction Drivers 38
Section Summary 39
Decision Making for Late Phase Studies 40
Sponsors' Departmental Responsibilities 41
Summary of Sponsor Departmental Responsibilities 41
Service provider selection by study type 43
Selection for Phase IIIb Studies 43
Selection for Phase IV Studies 44
Selection for Comparative Effectiveness Studies 45
Selection for Registry Studies 46
Selection for Health Outcomes Studies 47
Drivers of Service Provider Non-Awards 49
Drivers of Non-Awards 49
Section Summary 50
Study Data 51
Service Provider Perceptions 52
Awareness 52
Industry Leaders 52
Provider familiarity 53
Provider Usage 54
Preferred Service Provider 55
Service Provider Familiarity and Use 56
Service Provider-Specific Data 56
AAI 56
Accenture 56
Cerner 57
Chiltern 57
Covance 58
DCRI-Duke 58
Eurofins 59
ICON 59
INC Research 60
McKesson 60
Medpace 61
OptumInsight 61
Paragon 62
PAREXEL 62
PharmaNet / i3 63
PPD 63
PRA 64
Premier Research 64
Quintiles 65
Registrat-MAPI 65
Rho 66
SGS Life Sciences 66
Theorem 67
UBC 67
Late Phase Decision-making 68
Biopharma Departmental Responsibility 68
Designing Late Phase Studies 69
Late Phase Outsourcing Decision 70
Holds the Late Phase Budget 71
CRO Bid Invitation Responsibility 72
CRO Selection Responsibility 73
CRO Management/ Delivery Responsibility 74
Service Provider Selection Criteria 75
Phase IIIb Studies 75
Phase IV Studies 76
Comparative Effectiveness Studies 77
Registry Studies 78
Health Outcomes Studies 79
Late Phase studies: Service Provider Selection Criteria Summary … 80
Reasons Why Providers Lose Bids 82
Service Provider Satisfaction Drivers 83
Market Size and Opportunity 84
Growth/ Decline in the Number of Late Phase Studies 84
Growth/ Decline in the Number of Outsourced Late Phase Studies 85
Late Phase Study Opportunity 86
Study Outsourcing Trends 87
Phase IIIb 87
Phase IV 88
Comparative Effectiveness 89
Registry Studies 90
Health Outcomes Studies 91
Anticipated Outsourcing of Dollars for Late Phase (next 12 months) 92
Phase IIIb 92
Phase IV 93
Comparative Effectiveness 94
Registry studies 95
Health Outcomes Studies 96
Late Phase Funding Sources, Past 3 Years 97
Distribution of Late Phase Studies - Interventional vs Observational, Past 3 Years 98
Interventional Designs - Distribution of Study Purpose, Past 3 Years 98
Interventional Designs - Distribution of Intervention Model, Past 3 Years 99
Interventional Designs - Distribution of Masking Strategies, Past 3 Years 99
Interventional Designs - Subject Allocation Models, Past 3 Years 100
Interventional Designs - Classification of Endpoints, Past 3 Years 100
Observational Designs - Distribution of Study Models, Past 3 Years 101
Observational Designs - Distribution of Time Perspective, Past 3 Years 0101
Average Phase IV Study Length By Sponsor Type, Past 3 Years 102
Average Phase IV Study Enrollment By Sponsor Type, Past 3 Years 102
Average Interventional and Observational Study Length, Past 3 Years 103
Average Interventional and Observational Study Enrollment, Past 3 Years …… 103
Phase IV Study Target Age Groups, Past 3 Years 104
Interventional Study Target Age Groups, Past 3 Years 104
Observational Study Target Age Groups, Past 3 Years 105
Proving Comparative Effectiveness 106
Phase IV study types trends to 2014 107
Emerging Markets - Late Phase Patient Recruitment 108
About Industry Standard Research 109




Companies Mentioned

AAI
Accenture
Cerner
Chiltern
Covance
DCRI-Duke
Eurofins
ICON
INC Research
McKesson
Medpace
OptumInsight
Paragon
PAREXEL
PharmaNet/ i3
PPD
PRA
Premier Research
Quintiles
Registrat-MAPI
Rho
SGS Life Sciences
Theorem
UBC

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