Overview

Companies

Metrics

Purchase

The list below covers the majority of the metrics included in Mastering Phase IV Clinical Trials, but it is not inclusive of all metrics contained in the report.

Budget Metrics:

• Average per-patient clinical trial costs in the US (by therapeutic area)
• Percentage of clinical development budgets outsourced for US-based trials (by therapeutic area)
• Percentage of total R&D spending allocated to Phase 4 trials
  
  

Staffing Metrics:

• Trial-specific staffing for 39 post-marketing trials covering more than a dozen therapeutic areas
  • including trial size, location(s), product type, trial management approach, number of patients, and number of sites
  • by the following clinical development functions and roles:
    • VPs and therapeutic area supervisors
    • trial managers
    • CRAs/monitors
    • data management
    • medical writing
    • biostatistics/bioanalytics
    • regulatory
    • clinical quality assurance
    • clinical trial supplies
    • CMC
    • contract management
    • drug safety
  • Percentage of staff outsourced by product type (small molecules vs. biologics vs. medical devices)
  • Patients-per-FTE by company size
  • Patients-per-CRA ratios
    

Performance Metrics:

• Phase 4 actual vs. projected trial durations/timelines
• Percentages of trial timelines consumed by various trial activities
• Percentage of surveyed companies that track various performance measures for:
  • Cycle times and time-based trial milestones
  • Resource allocation-based metrics (budgets and staffing)
  • Efficiency and operations-based measures
• Surveyed companies' actual and target performance metrics for:
  • Cycle times and time-based trial milestones
  • Resource allocation-based metrics (budgets and staffing)
  • Efficiency and operations-based measures
• Companies' self-assessments of their own performance measurement systems

Other Metrics:

• Number of active Phase 4 studies by company
• Companies' self-assessments of the key motivating factors that drive them to conduct Phase 4 research
• Percentage of company-sponsored vs. investigator-sponsored post-marketing trials
• Percentage of NDAs with at least one post-marketing study commitment
• Percentage of products with post-marketing studies conducted (by company size)
• Companies' self-assessments of various opportunities for trial acceleration
• Total number of patients enrolled in Phase 4 studies, on average, by therapeutic area
• Total number of patients per site
• Percentage of companies that have internal infrastructures in place to conduct Phase 4 research in house
• Percentage of companies that outsource Phase 4 activities
• Breakdowns of departments that oversee strategy and operations for Phase 4 research