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Clinical Trials |
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Mastering Phase IV Clinical Trials
Publication Date January 2007
Publisher Cutting Edge Information
Product Type Report
Pages 152
ISBN Number not applicable
Product Code CUT047
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Summary
Enhance Your Post-Marketing Trials:
Phase 4 is the fastest-growing area of clinical research today. At an annual growth rate of 23%, industry investment in post-marketing research is expected to top $12 billion in 2007. Rampant growth in Phase 4 research should come as no surprise, however. A changing regulatory environment, growing concerns about the safety of new medicines, and various uses for large-scale, real-world data on marketed drugs' safety and efficacy are primary drivers of the growth seen in the Phase 4 research environment today. Post-marketing research is an important element of commercialization that enables companies to expand existing markets, enter new markets, develop and deliver messaging that directly compares their products with the competition, and secure a niche position in crowded markets. What's more, payer groups and regulators are both requiring more post-marketing data from drug companies.
Given the increasing importance of post-marketing research, continued growth expected for Phase 4 trials, and mounting competitive pressures, it is critical for companies to make full use of the information and data available to them. Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy, and Benchmarks is a comprehensive post-marketing study management tool designed to provide industry executives with benchmark data and best practice information to inform key strategic and operational decisions in the areas of Phase 4:
- Trial management structure and oversight
- Research strategy
- Study design and execution
- Study timelines and cycle times
- Performance metrics and management
- Operational activities
- Trial budgeting and outsourcing
- Trial staffing
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Content
- The List below Covers The Majority of The Metrics Included in 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
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