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Clinical Trials

Clinical Operations

Accelerating Trials, Allocating Resources and Measuring Performance

Publication Date   September 2006
Publisher   Cutting Edge Information
Product Type   Report
Pages   182
ISBN Number   not applicable
Product Code   CUT040
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Price £2,220.00

approximately: $4,148 | €2,816

Summary


Clinical Operations: Accelerating Trials, Allocating Resources & Measuring Performance is a comprehensive tool designed to help clinical trial operations departments, trial managers, and clinical development function heads benchmark performance and generally enhance clinical operations at their companies.

The report covers operational performance enhancement and clinical benchmarking from several angles, including:

  • Clinical Trial Resource Allocation Benchmarks - This section of the report analyzes clinical trial budgets and staffing levels by development phase (including Phase 1, Phase 2, Phase 3 and Phase 4 studies) and therapeutic area. Budgeting benchmarks are provided for several therapeutic areas, including analgesia and rheumatology, autoimmune diseases, cardio and thrombosis, CNS/psychology, gastroenterology, infectious diseases, musculoskeletal and oncology, among others. Trial-specific staffing data from more than 70 clinical trials are included. Staffing data are segemented for all key clinical development roles and functions, including therapeutic area heads, clinical trial managers, CRAs, data management, medical writing, biostatistics/bioanalytics, regulatory, clinical quality assurance, clinical trial supplies, contracts management, CMC and drug safety.
  • Clinical Operations Performance Measurement - The report also analyzes key performance indicators used by clinical development organizations to drive continuous process improvement. Performance measures are divided into three main categories, including time-based milestones/cycle times, resources (budgets/costs and staffing), and efficiency and operational quality metrics. Surveyed companies provide actual and target performance benchmarks for a variety of metrics in these three categories.
  • Continuous Process Improvement - A dozen of the most consistently troublesome and time-consuming clinical development bottlenecks are analyzed in case study format. Executives consulted in the development of this report provide their innovative suggestions for removing these bottlenecks and accelerating overall clinical development. Also, the report dedicates a full chapter to two areas that are often cited as the most costly and time consuming aspects of trial operations: patient and investigator recruitment and retention.

Content


  • Budget Metrics:
    • Average per-patient clinical trial costs in the US
      • -by therapeutic area
      • -by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)
    • Percentage of clinical development budgets outsourced for US-based trials
      • -by therapeutic area
      • -by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)
    • Cost savings of clinical trials in India
  • Staffing Metrics:
    • Trial-specific staffing for 71 clinical trials covering about 10 therapeutic areas
      • -including trial size and location(s)
      • -by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)
      • -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 in-house and outsourced staff
      • -by therapeutic area
      • -by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)
    • Patients per CRA
      • -by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)
      • -by company size (small, mid-sized and large sponsors)
  • Performance Metrics:
    • 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
    • Surveyed companies' assessments of metrics that have power to affect organizational change for:
      • -Cycle times and time-based trial milestones
      • -Resource allocation-based metrics (budgets and staffing)
      • -Efficiency and operations-based measures
  • Other Metrics:
    • Factors impacting rising clinical development costs in the US (2006 vs. 2004)
    • Average number of patients per trial
      • -by therapeutic area
      • -by development phase (Phase 1, Phase 2 and Phase 3)
    • Percentages of trials consumed by various trial activities
    • Marketing tactics' impact on patient recruitment
    • Surveyed companies' rankings of opportunities for trial acceleration
    • Surveyed companies' rankings of patient recruitment incentives
    • Surveyed companies' rankings of investigator recruitment tools
    • Surveyed companies' rankings of investigator incentives