Clinical Development and Trial Operations (PH192)

Protocol Design and Cost Per Patient Benchmarks
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  • Minimize Clinical Trial Costs, Accelerate Timelines and Incorporate Risk-Based Monitoring Strategies

    Trial costs and patient recruitment delays are top challenges directly addressed in this benchmarking study.  The report is designed to provide clinical development executives the decision making tools necessary to minimize these challenges and arrive at successful clinical endpoints. 

    The data include key performance indicators, such as cost per patient, trial duration, patients per clinical research associate (CRA) and patient recruitment and retention metrics presented across all development phases.  Where possible, the data are broken down for 25 therapeutic areas to present a comprehensive decision support resource.

    The study also includes current trend analysis of changes to clinical development strategy.  It provides insights into top pharmaceutical and biotechnology companies’ approaches to preventing significant threats to data and patient security through risk-based monitoring. 

     

    Key Questions that This Study Answers

    1. What factors impact clinical trial costs the most and how can companies reduce that impact?
    2. What is the average cost-per-patient for a clinical trial in my therapeutic area?
    3. What are some best practices to boost clinical trial recruitment and retention?
    4. What leading roles are included within companies’ clinical teams?  How do companies align these roles?
    5. How will risk-based monitoring alter clinical development strategies?

     

    Top Reasons to Review This Report

    Reduce and Avoid Costly Trial Delays:  The average delay in a clinical trial’s durations is 25% beyond the expected timeline.  The report includes recommendations from experienced drug developers and CROs that have implemented best practices for minimizing clinical trial delays, managing non-performing sites and accelerating site initiation and contracting.  Furthermore, the report’s data reveal how much time and money companies should invest to not only plan for trial delays, but also to avoid them completely.

    Benchmark Clinical Development Costs: 
     Clinical trial costs rise in tandem with healthcare costs, but other market forces also have a profound impact on clinical development investment.  Early-stage trials have shown a dramatic rise in per-patient costs as clinical teams look to collect more data earlier in the drug development process.  Overall trial costs are also rising.  Compare per-patient costs for each drug development phase in 25 therapeutic areas. 

    Balance In-house Resources with Outsourced Expertise:  Sponsor companies share the need to recruit experienced trial staff to run clinical studies.  Several factors — including development phase and therapeutic area — drive trial staffing decisions.  The report provides key recommendations for vendor/CRO management.  Benchmark your company’s clinical outsourcing performance using detailed metrics for more than 450 trials across multiple therapeutic areas. 

    Adopt Patient Centric Strategies:  The industry’s trend toward patient-centric models has impacted clinical development.  Drug manufacturers now design clinical protocols that center on patients, providing exceptional care and lessening the burden of participating in research.  Use this report to learn how companies improve investigator and site support through patient-centric protocol development.  Create understandable and easily implemented protocols that remove large burdens from the patients. 

     

     

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  • Clinical Development and Trial Operations Metrics

     

    Chapter 1: Aligning Trial Structure with Clinical Strategy

    Chapter Benefits

    • Examine case studies to compare your clinical team structure to those from a like-sized/similar company.
    • Track the advantages of centralized and decentralized structures as companies enable clinical teams to focus on specific therapeutic areas.
    • Explore cross-functional involvement in study design and management among companies providing optimal clinical trial support.

     

    Chapter Data

    Eight (8) charts focused on clinical group structure and reporting relationships.  Companies’ clinical operations structures (e.g., completely centralized, decentralized by therapeutic area, by region or business unit).

    • Number of therapeutic areas studied, by company type (large, mid-sized, small pharma, biotech and CRO)
    • Number of companies conducting clinical trials, by therapeutic area
    • Diagrams of clinical teams, by company type:
      • Large pharma
      • Mid-sized pharma
      • Small pharma
      • Biotech
      • CRO

     

     

    Chapter 2: Developing Robust Clinical Team Staffing and Outsourcing Strategies

    Chapter Benefits

    • Discover the qualities of an ideal CRA and strengthen relationships with contracted sites.
    • Prevent CRA burnout with new strategies for better managing workloads.
    • Use staffing benchmarks to allocate resources appropriately and keep project timelines on schedule.
    • Follow industry leaders’ recommendations for developing an outsourcing strategy and selecting the right vendor.

     

    Chapter Data

    41 charts detailing CRA staffing and outsourcing trials.  Charts include patients per CRA and sites per CRA for trials in 16 therapeutic areas.

    Trial Staffing

    • Average ratio of patients per CRA, by development phase
    • Average ratio of investigator sites per CRA, by development phase
    • Trials’ total CRA staffing, by therapeutic area
    • Patients per CRA and sites per CRA in:
      • Cardiovascular trials
      • Central Nervous System trials
      • Dermatology trials
      • Diabetes (Type 2) trials
      • Endocrinology trials
      • Gastroenterology trials
      • Hematology trials
      • Infectious disease trials
      • Medical device trials
      • Musculoskeletal trials
      • Early-stage oncology trials
      • Late-stage oncology trials
      • Respiratory trials
      • Rheumatology trials
      • Urology trials
      • Women’s health trials


    Trial Costs Outsourced

    • Percentage of companies outsourcing some portion of clinical trial costs
    • Percentage of total trial cost outsourced, by company type (top 20, top 50, small, biotech and device)
    • Average number of outsourced staff, by subgroup
    • Percentage of companies that outsource clinical operations staffing
    • Percentage of total trial cost outsourced, by development phase and therapeutic area

     

     

    Chapter 3: Protocol Design and Site Management

    Chapter Benefits

    • Boost patient enrollment and retention by designing
      protocols that reduce patient burden.
    • Employ risk-based monitoring to prevent significant threats to data and patient security. 
    • Use patient screening rates to gauge protocol feasibility and uncover weaknesses in trial design.
    • Learn the benefits and uses of adaptive design — including when it is most beneficial in trials.
    • Time protocol submissions strategically to ensure approval from the IRB/ethics boards.
    • Determine the ideal number of trial sites by weighing trial factors and comparing data benchmarks.
    • Improve and prioritize communication strategies to encourage full cooperation from sites.

     

    Chapter Data

    14 charts detailing protocol development planning and site management:

    • Time spent (in months) planning protocol, by phase
    • Time (in months) to earn IRB/ethics approval by phase
    • Number of office visits required by protocol, by phase and by therapeutic area
    • Amendments per protocol by phase and therapeutic area
    • Patient screening rates, by phase and therapeutic area
    • Trials using adaptive design, by phase
    • Number of investigator sites used, by phase
    • Ratio of patients per investigator site, by phase and by therapeutic area
    • Percentage of non-performing sites, by phase and by therapeutic area

     

     

    Chapter 4: Conducting Efficient Clinical Trials

    Chapter Benefits

    • Pinpoint how and at which point trials become delayed —
      and learn how other teams keep projects on track.
    • Save time and money by investing upfront and engaging
      long-term planning to prevent expensive delays down the road.
    • Learn new tactics for understanding patient motivation —
      an essential factor in improving recruitment and retention rates.
    • Create a detailed action plan to support sites in recruitment efforts.


    Chapter Data

    15 charts detailing trial duration, delays, number of enrolled patients and number of months to achieve trial milestones.

    • Duration for clinical trials, by phase
    • Delay (by percentage) for clinical trials by phase and by therapeutic area
    • Number of patients enrolled in clinical trials, by phase
    • Average number of months to achieve specific trial milestones, by phase
    • Delay in achieving specific trial milestones, by phase
    • Patient retention rate, by phase

     

     

    Chapter 5: Clinical Trial Budgets and Per-Patient Costs

    Chapter Benefits

    • Understand the factors — including drug safety requirements —
      leading to delays in approval and rising costs.
    • Build a robust benefit-risk profile with carefully selected safety endpoints
      and solid patient enrollment targets.
    • Know how and when to incorporate HEOR and CER data to build a better understanding of a drug’s value.
    • Understand the budget implications of collecting CER data — comparator drugs can constitute 10% of a trial’s total cost.
    • Benchmark total and per-patient costs across a range of therapeutic areas to gain a clear picture of clinical investments.


    Chapter Data
    62 charts detailing clinical trial costs, including per-patient cost and total trial cost across phases for 25 therapeutic areas.

    • Average per-patient clinical trial costs: all therapeutic areas
    • Average total cost for clinical trials by phase: all therapeutic areas

     

    Therapeutic Areas Covered:

    • Arthritis (non-rheumatic)
    • Autoimmune — total trial cost only (no per-patient metrics)
    • Cardiovascular diseases
    • Cardiology and thrombosis — total trial cost only (no per-patient metrics)
    • Central nervous system — total trial cost only (no per-patient metrics)
    • Dermatology
    • Diabetes (Type 1) — total trial cost only (no per-patient metrics)
    • Diabetes (Type 2)
    • Endocrinology/metabolic diseases (non-diabetes)
    • Gastroenterology
    • Hematology
    • Immunology/vaccines — total trial cost only (no per-patient metrics)
    • Infectious disease
    • Inflammation — total trial cost only (no per-patient metrics)
    • Mental health/psychology — total trial cost only (no per-patient metrics)
    • Musculoskeletal
    • Oncology
    • Respiratory
    • Rheumatic diseases/rheumatology
    • Urology
    • Virology — total trial cost only (no per-patient metrics)
    • Women’s health

     

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  • Clinical Operations Report Sample

     

    The following is a key finding excerpted from the full report's Executive Summary:

    Early-Stage Clinical Trial Costs Rise; Late-Stage Costs Level Off

    The past five years have seen a dramatic rise in per-patient clinical trial costs.  Excluding post-marketing trials, costs in each drug development stage have experienced more than a 60% rise in costs between 2008 and 2013 — with early-stage trials experiencing triple-digit growth.  In 2008, average per-patient costs for a pivotal Phase 3 trial hovered near $25,000.  Recent data show costs have nearly doubled in five years, with the average Phase 3b trial now costing $48,500 per-patient.  And while pivotal studies saw a dramatic cost increase between 2008 and 2011, new data indicate that per-patient costs in Phase 3 trials have leveled off in 2013. 

    Higher trial costs are not only a late-stage phenomenon.  Early-stage trials have experienced higher cost increases on both a dollar and percentage basis.  Phase 1 trial costs experienced the largest increase, rising $23,600 per patient, or 157% in the past five years.  Phase 2 trials were not far behind, rising 108% during the same time period.

    In order to discuss the rising costs of clinical trials, it is important to mention some of the market forces affecting changes to research and development.  Many micro and macroeconomic factors impact clinical trials.  Interviewed executives cited the following three healthcare trends as driving forces:

    • Emphasis on drug safety data
    • New demand for health economics and outcomes research (HEOR)
    • Shifting toward personalized medicine and orphan drug development

    In the wake of several high-profile drug recalls, government regulators have shown a renewed focus on safety data.  Patient safety has always been important.  Today, however, regulators including the FDA do not hesitate to ask for more safety data before approving a new drug.  One interviewed clinical director admitted that safety data has taken top priority for her team.  “Safety is the new efficacy,” she said, describing the changing times…

    (more details included in the full report)

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