Clinical Operations: Benchmarking Per-Patient Trial Costs, Staffing and Adaptive Design
Cutting Edge Information
January 1, 2011 174 Pages - SKU: CIGQ6277109
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The current patent cliff, shrinking pipelines, and the impact of a global recession place heightened pressure on the clinical development landscape. As competition intensifies for investigators, sites and patients, trial costs have reached unprecedented levels, causing drugmakers to adopt a bottom-line perspective and demand greater R&D efficiency. Greater efficiency leads to cost- and time-savings that could mean the difference in beating the competition to market and adding time to a drug's lifecycle.
Successful teams win this race by minimizing risks, eliminating trial unknowns and hitting study deadlines. Supported by ample resources, they build process improvements through performance measurement and charge ahead with new techniques to accelerate trial timelines.
Designed to benefit teams and individuals in any role in the clinical trials space, this study will help teams achieve clinical operations efficiency - and realize the significant payoffs that accompany successful drug development:
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- Chapter 1: Clinical Trial Costs and Outsourcing
- Chapter Benefits:
- Benchmark trial costs with per-patient data across key therapeutic areas
- Use the data to allocate resources wisely and drive decision making
- 41 data charts focused on the following:
- Factors most responsible for increased clinical trial costs
- Average per-patient clinical trial costs across all therapeutic areas - 2008 and 2011
- Average percentage of clinical trial costs outsourced across all therapeutic areas - 2008 and 2011
- Per-patient clinical trial costs, broken down by phase, for these therapeutic areas:
- Cardiovascular
- Oncology
- Central Nervous System
- Diabetes
- Hematology
- Average percentage of clinical trial costs outsourced across all therapeutic areas - 2008 and 2011
- Chapter 2: Budgets, Staffing and Performance Measurement
- Chapter Benefits:
- Right-size your clinical teams
- Ensure adequate resources for 12 key clinical positions at every development stage.
- Compare real-life staffing for 100 clinical trials
- Find the right level of vendor involvement for your company
- 31 charts focus on clinical staffing data, and 5 tables provide staffing figures broken down by phase:
- Total trial staffing by phase
- Overall percentage of staffing outsourced by phase
- Average patients and average sites per CRA, by phase
- These metrics are broken down by phase:
- Actual patients/sites per CRA
- Clinical trial staffing and average staffing by position
- Average percentage of FTEs outsourced by phase:
- CRAs/monitors
- Trial managers
- Clinical directors/VPs & TA program supervisors
- Data management
- Medical writing
- Biostatistics/bioanalytics
- Average percentage of regulatory FTEs outsourced by phase
- Clinical Quality Assurance (QA)
- Clinical trial supplies
- Chemistry Manufacturing and Controls (CMC)
- Contract management
- Drug safety
- Chapter 3: Clinical Trial Performance Metrics
- Chapter Benefits:
- Track clinical trial performance to fine-tune operations and boost efficiency.
- Identify the 3 critical areas that need to be measured - and develop a balanced performance measurement process.
- Learn what metrics companies are tracking, and when.
- Learn the benefits of new software to improve forecasting and trial results.
- 19 charts focused on these clinical development topics:
- Average number of metrics collected by phase
- Prevalence of time, operations and resource metrics collected across all clinical trials and broken down by phase
- Timing
- Average time to close a database
- Average time to initiate an investigational site
- On-time protocol completion
- Time to completion of clinical trial
- Time from statistical tables complete to clinical trial report complete
- Time from database lock to statistical tables complete
- Time from first patient in (FPI) to last patient out (LPO)
- Time from last patient in (LPI) to last patient out (LPO)
- Time from last patient out (LPO) to database lock
- Time from last patient out (LPO) to statistical tables complete
- Time to randomize a target number of patients
- Time to enroll a target number of patients
- Resources
- Overall cost per patient enrolled
- Overall cost per patient randomized
- Cost per clean Clinical Research Form (CRF) page
- Budget to completion of a trial
- Patients per CRA
- Sites per CRA
- Operations
- Investigator recruitment rates
- Case report forms collected per CRA per day
- Patient enrollment rates (per site)
- Patient retention rates
- Patient randomization rates (per site)
- Site retention rates
- Advertising/marketing results
- Data error rates
- Chapter 4: Adaptive Clinical Trials
- Chapter Benefits:
- Deepen your understanding of adaptive design with the chapter's penetrating look at the FDA's new guidance.
- Weigh drawbacks and advantages of adaptive design as you explore different companies' approaches.
- Save time with adaptive trials and fully understand their impact on trial costs.
- Use the right adaptive design to fit your needs - learn which ones are prevalent industrywide.
- 13 charts focusing on adaptive design:
- Percentage of companies using adaptive design in clinical trials
- Rating adaptive clinical trials design effectiveness versus traditional clinical trials design
- Percentage of adaptive design usage in clinical trials by development stage
- Likelihood of adaptive design usage in clinical trials by development stage
- Impact of adaptive design usage in clinical trials on trial cost, aggregate and by company
- Impact of adaptive design usage in clinical trials on trial duration, aggregate and by company
- Importance of factors for using adaptive design in clinical trials
- Percentage of companies that unblind data during interim analyses in adaptive clinical trial designs
- Percentage of companies using third party or DMC during interim analyses in adaptive clinical trial designs
- Prevalence of usage of adaptive design types, aggregate and by company
- Appendix: Continuous Process Improvement
- Discover solutions and best practices to solve over a dozen clinical trial bottlenecks with 3 charts focused on these topics:
- Impact of narrowing data collection targets early in clinical trials
- Opportunities for trial acceleration in investigator and CRO/vendor contracting
- Solving the non-disclosure agreement bottleneck
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