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  4. > 2014-2018 Phase I Study Trends and Market Outlook

2014-2018 Phase I Study Trends and Market Outlook

  • October 2014
  • -
  • Industry Standard Research
  • -
  • 91 pages

Staying up-to-date with industry practices and usage patterns in this critical stage of clinical development is essential to making informed decisions regarding your own Phase I research, regardless of whether you work at a sponsor organization or a service provider.

This report provides an overview of current market dynamics in the Phase I space as well as an outlook of what our survey respondents, all Phase I decision-makers at sponsor organizations, envision the marketplace will look like in 2018.

ISR also explores the perceptions and selection of Phase I service providers. Understanding these dynamics can help both study sponsors and CROs better evaluate their position in the marketplace and prepare for upcoming changes and new trends.

What you will learn in this report:

- 4-year examination of the industry’s Phase I market dynamics (i.e. study volume, outsourcing, spend)
- Average per company spend on Phase I studies and dollar value of outsourced studies
- Criteria sponsors use to select (and disqualify) clinical service providers
- Sponsor predictions and preferences for future changes in Phase I studies
- Detailed examination of service provider selection for simple vs. complex studies

How you can use this report:

For Sponsors: Evaluate your position in the marketplace and prepare for upcoming changes or new trends.
Benchmark your Phase I outsourcing practices against industry-wide trends to make more informed operational, resourcing, and financial decisions.

For Service Providers: Drive operational and Phase I sales and marketing strategies by understanding sponsor preferences, most important service provider attributes, and reasons service providers lose bids. Develop strategies based on current trends and Phase I study volume and outsourcing projections for the next 4 years.

Table Of Contents

2014-2018 Phase I Study Trends and Market Outlook
Table of Contents

Copyright and Usage Guidelines 4
Introduction 5
Methodology 6
Respondent Demographics and Qualifications 7
Participant Geography 7
Participant Company Size 7
Late Phase Market Dynamics 8
Outsourcing Decision-Making 9
Late Phase Study Volume 11
Anticipated Change in Number of Late Phase Studies 11
Anticipated Change in Number of Outsourced Late Phase Studies 12
Percent of Late Phase Budgets Outsourced 13
Expected Spend with CROs 14
Service Provider Familiarity 16
Late Phase Trends 17
Complexity and Global Nature of Studies 17
Use of Technology 18
Service Provider Perceptions and Selection 19
Most Important Service Provider Attributes 20
Average Service Provider Attribute Importance - Across Study Types 20
Top 5 Most Important Attributes per Study Type 21
Critical Attributes for Late Phase Service Providers 22
Reasons Service Providers Lose Bids 24
CRO Satisfaction Drivers 25
Number of Preferred Providers 26
Study Data 27
Late Phase Market Dynamics 28
Anticipated Change in Number of Late Phase Studies 29
Anticipated Change in Number of Outsourced Late Phase Studies 29
Percent of Late Phase Budget Outsourced 30
Expected Spend with CROs: Phase IIIb Services 31
Expected Spend with CROs: Phase IV Services 32
Expected Spend with CROs: Comparative Effectiveness Studies 33
Expected Spend with CROs: Registry Studies 34
Expected Spend with CROs: Health Outcomes Studies 35
Phase IV Study Budget Allocation: Current 36
Phase IV Study Budget Allocation: 2018 37
Allocation of Responsibility: Designing the Late Phase Study 38
Allocation of Responsibility: Deciding Whether to Outsource Study 39
Allocation of Responsibility: Holding the Budget for Study Conduct 40
Allocation of Responsibility: Deciding Which CROs to Invite to Bid 41
Allocation of Responsibility: Making the Final CRO Selection 42
Allocation of Responsibility: Directly Managing the CRO Delivery 43
Emerging Market Use 44
Service Provider Perceptions and Selection 45
Most Important Service Provider Attributes - Phase IIIb studies 45
Most Important Service Provider Attributes - Phase IV Studies 46
Most Important Service Provider Attributes - Comparative Effectiveness Studies ……………47
Most Important Service Provider Attributes - Registry Studies 48
Most Important Service Provider Attributes - Health Outcomes Studies 49
CRO Satisfaction Drivers 50
Reasons Service Providers Lose Bids 51
Service Provider Familiarity 52
Number of Preferred Providers - Current 53
Number of Preferred Providers - In 2018 54
Difficulty Using a Non-Preferred Provider 55
Service Provider Use 56
Service Provider Preference 57
Late Phase Trends 58
Importance of Technology 58
Complexity 59
Global Nature 60
Use of Electronic Medical Records (EMR) 61
Critical Attributes for Late Phase Service Providers 62
Respondent Demographics 63
Company Type 64
Decision Making Responsibility 65
Drug Development Responsibilities 66
Job Title 69
Involvement in Outsourced Activities 68
Involvement in Drug Development Process 69
Respondent Location 70
Drug Development Involvement by Phase 71
About Industry Standard Research 72

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