Adaptive Trial Market Dynamics -





Published: Q4, 2012 | Pages: 57 


 
Pharmaceutical companies are under tremendous pressure to lower costs and improve the ROI on their R&D spending. How bad is it? In a relatively unprecedented move, large pharmaceutical companies have actually come together to work together for the sole purpose of reducing clinical trial costs.

 
Pharmaceutical companies have collaborated before on areas considered not directly competitive, like finding variants in the human genome and biomarkers to predict disease and the effectiveness of drugs. But the people behind the new effort said it would be the largest of its kind.

  
Major Report Sections:
 
  • Adaptive Trial Market Dynamics (i.e. growth and adoption; perceptions of how risky adaptive trials are) 
  • Outsourcing Environment (including service provider analyses)
  • Study-specific Usage and Trends
  • Departmental/ Organizational Impacts
 
What You’ll Learn:
 
  • Compare your own organizations activities against the industries level of adoption 
  • The types of studies conducted most frequently, those that are given the most attention, and whether adaptive trials are gaining/losing momentum 
  • Sponsors’ drivers for conducting adaptive trials and the common barriers standing in the way of adoption 
  • Which service providers are perceived as leaders in adaptive clinical trials, which are used most often, and who has the most proposal activity 
  • The therapeutic areas that are most attractive and best fit for adaptive designs
 
Actionable Insight:
 
  • Identify trends in adaptive trial conduct and outsourcing (i.e. drivers and barriers, outsourcing trial design vs. clinical operations, levels of adoption, etc.) 
  • Set realistic goals by understanding sponsors’ expectations for adaptive trial timing and cost 
  • Make more informed decisions regarding marketing messages and customer targeting
 
  

 

Table of Contents

 
Adaptive Trial Market Dynamics 1
Copyright and Usage Guidelines 5
Methodology 6
Introduction 7
Executive Summary 8
Market Dynamics 9
Growth and adoption 9
Adoption momentum of adaptive trial designs within Pharma 9
Why adaptive designs are gaining momentum 10
Why adaptive designs are losing momentum 11
Historic adaptive clinical trial penetration 12
Future penetration of adaptive clinical trials 13
Drivers for conducting adaptive clinical trials 15
Barriers to adaptive trial adoption 16
Potential drawbacks to adaptive trials 17
Likelihood to continue conducting adaptive trials 18
Clinical development outsourcing penetration 19
Perceptions of how risky adaptive trials are 20
Relative timing for completing adaptive clinical trial 21
Relative cost of adaptive trials 22
Adaptive clinical trials, biomarkers and personalized medicine 23
Section summary 24
Outsourcing Environment 25
Outsourcing penetration 25
Outsourcing of adaptive statistical design 26
Outsourcing of clinical operations component 27
Comfort level with outsourcing aspects of adaptive design 28
Most important attributes in selecting an adaptive trial service provider 29
Important service provider capabilities 30
Most used adaptive trial software packages 31
Awareness of clinical operations execution technologies 32
Service provider analysis 34
Perceived leaders in the field 34
Proposal activity 35
Use of service providers for adaptive trials 36
Service provider evaluations 38
Section summary 39
Study-specific Usage and Trends 40
Current and future types of adaptive trials being run 40
Anticipated growth in specific adaptive trial designs 41
Most attractive therapeutic areas for adaptive trials 42
Section summary 43
Departmental/ Organizational Impacts 44
Clinical departments most affected by adaptive trial design 44
Impact of change management on adaptive trial adoption 45
Presence of a task force for implementing adaptive design trials 46
Section summary 47
Respondent Demographics 48
Company characteristics 48
Organization type 48
Organization size 49
Respondent job title 50
Respondent and company HQ location 51
Decision-making responsibility 52
Primary decision-making responsibility 53
Adaptive clinical trials responsibility 54
Development responsibility by phase 55