Phase II/III Study Trends and Market Outlook (2018-2022)

Description

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Welcome to ISR’s Phase II/III Study Trends and Market Outlook (2018-2022) report preview. Keeping up-to-date with the evolving pharmaceutical market is no easy task. The constant flow of newsletters hitting our inboxes is almost too much to wade through. But stay abreast of the market we must. To this end, ISR publishes a series of Study Trends and Market Outlook reports aimed at providing our readers with a high-level view of the clinical development space. For this report, 139 Phase II/III decision-makers were surveyed to share their insights into where the Phase II/III market is now and where it’s expected to head over the next four years.

Phase II/III Study Trends and Market Outlook

What you will learn:

  • 4-year examination of the industry’s Phase II/III market dynamics (i.e. study volume, outsourced spend)
  • Average dollar value of outsourced Phase II/III studies and how this varies by sponsor size
  • How Phase II/III spend is divided between large CROs, mid-size CROs, small/niche CROs, and AMCs – how this varies by sponsor size and how it is expected to change over time
  • Which roles have the most responsibility for each of six different decisions related to Phase II/III study outsourcing
  • Evolution of trends in the Phase II/III market (e.g. expansion into developing markets, evolving study complexity, and use of methods such as Real-World Evidence, patient centricity, non-traditional monitoring, ePRO, sensors/patches, and activity trackers, etc.)

How you can use this report:

  • Gain understanding of the key decision-makers within sponsor organizations to develop more targeted communications
  • Learn the most desirable characteristics of a Phase II/III service provider
  • Ensure your Phase II/III outsourcing practices are industry standard or better

For Pharma:

  • Use the predictions of your peers to identify in what types of studies your competition is investing resources and understand how your company’s strategy compares to that of the industry.

For CROs:

  • Utilize this information to ensure your capabilities and capacity are in line with the study types and volume that will be needed in the near future.

Executive Summary

  • Market Dynamics
  • Provider Selection
  • Trends and Predictions

Study Data

Demographics

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

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Phase II/III Study Trends and Market Outlook

Executive Summary

Market Dynamics

Spend on Phase II/III studies
Outsourced proportion of Phase II/III spend
Forces leading to an increase in Phase II/III outsourcing
Forces leading to a decrease in Phase II/III outsourcing
Average value of outsourced Phase II/III study
Largest study comfortable awarding to each provider type
Outsourced spend by provider type

Provider Selection

Decision-making influence by role
Number of preferred providers
Difficulty using non-preferred providers
Desired provider characteristics
Provider selection attributes

Trends and Predictions

Locations of Phase II/III studies
Recruiting in China and India
Preference for small CROs
Working solely with large CROs
Consolidation of CRO spend
Sponsor interest in pediatric and orphan drug develop
Incorporation of various drug development trends in clinical trial protocols

Study Data

Market Dynamics

Spend on Phase II/III studies
Outsourced proportion of Phase II/III spend
Average value of outsourced Phase II/III study
Largest study comfortable awarding to each provider type
Forces leading to an increase in Phase II/III outsourcing
Forces leading to a decrease in Phase II/III outsourcing
Outsourced spend by provider type
Benefits of large, full-service CROs
Benefits of using mid-size, multi-service CROs
Benefits of using small or niche service CROs
Benefits of using Academic Medical Centers
Locations of Phase II/III studies

Provider Perceptions and Selection

Number of preferred providers
Difficulty using non-preferred providers
Service provider familiarity
Service provider use
Service provider preference
Desired provider characteristics
Provider selection attributes
Reasons providers lose bids
Decision-making influence: Designing the Phase II/III study
Decision-making influence: Deciding whether to outsource study
Decision-making influence: Holding the budget for study conduct
Decision-making influence: Deciding which CROS to invite to bid
Decision-making influence: Making the final CRO selection
Decision-making influence: Directly managing CRO delivery

Trends and Predictions

Preference for smaller CROs
Working solely with large CROs
Study size impact on CRO consideration
Consolidation of CRO spend
Recruiting in China
Recruiting in India
Change in sponsor interest in orphan drug / rare disease compounds
Change in sponsor interest in pediatric drug development
Incorporation of various drug development trends in clinical trial protocols
Adaptive design use
Change in adaptive trial use
Risk-based monitoring use
Change in risk-based monitoring use
Use of multiple countries
Change in conducting trials in multiple countries
Change in use of hospitals or academic centers

Demographics

Company size
Areas of responsibility
Drug development responsibilities
Respondent location
Job title
Recent outsourcing involvement
Drug development involvement
Drug development involvement by phase

Additional information

License

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