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2013 Phase I Study Trends and Market Outlook - Product Image

2013 Phase I Study Trends and Market Outlook

  • ID: 2739730
  • April 2013
  • 72 Pages
  • Industry Standard Research (ISR)

This report surveyed 119 respondents with responsibility and decision-making for Phase I study conduct and outsourcing activities. This report provides novel, first-hand insight into phase-specific study trends and the use of service providers for Phase I studies.

2013 Phase I Study Trends and Market Outlook
Copyright and Usage Guidelines
Methodology
Study Findings
An Analysis of Phase I Market Dynamics
Study Volume
Phase I Study Volume
Phase I Study Complexity
Study Outsourcing
Phase I Outsourcing Proportions
In-House Capabilities
Value of Phase I Studies
Proportion of Spend Among Service Providers
Selection of Phase I Service Providers
Phase I Service Provider Use
Preferred Phase I Service Providers
Complex vs Simple Phase I Studies
Service Provider Attribute Importance for Complex Phase I Studies
Service Provider Attribute Importance for Very Simple Phase I Studies
Comparison Between Complex and Simple Study Attributes
Geographical Analysis
Current vs Future Phase I Studies by Region
Outlook for India
Appendix of Charts and Graphs
Respondent Demographics
Respondent Office Location
Organization Type
Organization Size by R&D Spending
Respondent Job Title
Area of Responsibility
Scope of Responsibility – In-House vs Outsource
Involvement in Drug Development Process
Recent Trial Involvement
Phase I Service Providers
Number of Preferred Providers
Phase I Service Provider Use
Preferred Phase I Service Providers
Reasons for Choosing Preferred Provider
Desirable Providers for Complex Phase I Studies
Service Provider Attribute Importance for Complex Phase I Studies
Desirable Providers for Very Simple Phase I Studies
Service Provider Attribute Importance for Very Simple Phase I Studies
Phase I Market Dynamics
Potential Reasons for Decreased Demand for Service Providers in Phase I
Change in Phase I Outsourcing Over Past 2 Years
Phase I Study Volume
Phase I Studies – Percent Outsourced
Dollar Value of Phase I Studies
Forces with Potential to Increase Phase I Studies
Forces with Potential to Decrease Phase I Studies
Current Proportion of Studies in Patients vs Healthy Volunteers
Future Proportion of Studies in Patients vs Healthy Volunteers
In-House Phase I Unit Ownership
Phase I Activity Outsourcing
Forces Affecting Phase I Outsourcing
Adaptive Trial Design
Phase I Study Outsourcing – Patient Populations
Phase I Study Outsourcing – Healthy Volunteers
Benefits of Using Large Full Service CROs
Benefits of Using Mid-Size Multi-Service CROs
Benefits of Using Dedicated Phase I Providers
Benefits of Using Academic Medical Centers
Current Phase I Studies by Region
Future Phase I Studies by Region
Current vs Future Phase I Studies by Region
Outlook on India for Phase I Studies
Trends in Phase I Study Characteristics
Patient Use
Phase I Study Complexity
Multiple Site Phase I Study Volume
Multiple Country Phase I Study Volume
Use of Hospitals or Academic Centers
Difficulty Finding Clinic / Bed Space
Desirable Service Provider Strengths
About Industry Standard

This report provides the pharmaceutical industry and its service providers with new insights into phase-specific trends affecting in-house and outsourced Phase I clinical trials.

“Of all the phases of clinical development, few are more dynamic and more in need of clarity than Phase I. ISR’s recently released report compiles data from those at the heart of the decision-making structure to understand how the conduct and outsourcing of Phase I studies is changing,” explained Kevin Olson, CEO of Industry Standard Research. “Seventy-seven percent of respondents agreed that Phase I studies are becoming more complex; drilling into the data reveals this may be a symptom of the expanded use of patient populations, non-traditional geographies, and more multi-site and multi-country designs.”

The report compiles data from 119 study managers, directors, and executives from sponsor organizations. All have responsibility for their organizations’ Phase I clinical trials.

In addition to the analysis of study trends, ISR’s report spends significant energy to quantify the proportion of studies outsourced, the dollar value of those studies, and sponsors’ in-house capabilities. The report also identifies sponsors’ preferences for 22 different service providers and uncovers strategies sponsors commonly use to determine whether to outsource Phase I studies.

“For sponsors and service providers alike, this report represents a wealth of actionable data to aid strategic, operational, and resource planning now and through 2016,” Olson explained.

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