Oncology Clinical Trials (PH180)

Drug Development Resources and Case Studies
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Published 2013
211 Pages
500+ Metrics
125+ Charts and Diagrams

Delve into Oncology Clinical Trials: The Most Research-Active Therapeutic Area

According to the US National Cancer Institute, 2012 saw 1.6 million newly diagnosed cancer cases and 577,000 cancer-related deaths in the US alone.  With such staggering numbers, oncology stands as one of the largest therapeutic areas within pharma research.  Life science companies spend, on average, $56.3 million and eight years to advance an oncology product from Phase 1 through Phase 3.  At every development stage, trial teams contend with key cost-drivers to maintain their budgets and timelines as they push their drugs to the finishing line.

This data-driven report focuses exclusively on Phase 1, 2 and 3 benchmarks for 29 oncology trials across more than 10 primary oncology indications.  It includes detailed trial case studies that create comprehensive snapshots to improve oncology trial operations.

 

Top Reasons to Buy this Report

Control budgets and accelerate timelines: Benchmark oncology trials of different sizes and durations with individual and average per patient and per patient per month costs for each development phase.  Compare average planned and actual trial durations while seeing how trial duration influences total costs — and see how outsourcing can help.

Manage critical cost-drivers: Track the shifting impact of key cost-drivers, such as patient enrollment and trial duration, as a product moves through development.  At the same time, see how an adequate number of sites encourages patient enrollment — a critical challenge for any trial.

Right-size your trial teams: Set optimal staffing levels for both CRAs and trial managers to handle trial sites and patients for each development phase — the report showcases average staffing for 12 key positions across all oncology phases.  Benchmark metrics such as number of sites per CRA and number of patients per CRA.

Oncology Trial Metrics

Chapter 1: Phase 1 Oncology Trials

Chapter Benefits

  • Compare key cost metrics across multiple Phase 1 trials, including:
    • Total trial cost
    • Percentage of costs outsourced
    • Cost per patient
    • Cost per patient per month
  • Examine staffing Phase 1 staffing trends across 12 key functions;
    • Leverage internal employees to drive trials
  • Measure the impact of key cost-drivers — patient enrollment and trial duration — on Phase 1 trial costs.
  • Leverage both patients and healthy volunteers to meet Phase 1 patient enrollment goals.
  • Review 11 Phase 1 oncology trial case studies detailing:
    • Trial background
    • Budget
    • Staffing
    • Patient enrollment
    • Duration



Chapter Data

14 charts detailing key trial cost, staffing and efficiency metrics for surveyed Phase 1 trials:

  • Total trial costs (by trial)
  • Percentage of costs outsourced (by trial)
  • Average planned and actual patient enrollment
  • Planned and actual patient enrollment (by trial)
  • Correlation between Phase 1 patient enrollment and trial costs
  • Cost per patient (by trial)
  • Actual duration (by trial)
  • Correlation between trial duration and trial costs
  • Cost per patient per month (by trial)
  • Average Phase 1 staffing (by position)
    • CRAs/monitors
    • Trial managers
    • Clinical program directors/leaders
    • Data management
    • Medical writing
    • Biostatistics/bioanalytics
    • Regulatory
    • Clinical quality assurance
    • Clinical trial supplies (CTS)
    • Chemistry, manufacturing and control (CMC)
    • Contract management
    • Drug safety
  • Number of patients per CRA (by trial)
  • Number of sites (by trial)
  • Number of patients per site (by trial)
  • Number of sites per CRA (by trial)

11 Phase 1 trial case studies showing the following benchmarks:

  • Trial background and budget
  • Cost metrics and staffing
  • Duration and enrollment

 

Chapter 2: Phase 2 Oncology Trials

Chapter Benefits

  • Compare key cost metrics across multiple Phase 2 trials, including:
    • Total trial cost
    • Percentage of costs outsourced
    • Cost per patient
    • Cost per patient per month
  • Examine staffing Phase 2 staffing trends across 12 key functions.
    • Leverage outsourcing in Phase 2 trial management to accommodate a smaller pool of internal staffing resources.
  • Measure the impact of key cost-drivers — patient enrollment and trial duration — on Phase 2 trial costs.
    • Explore the strong correlation between patient enrollment and Phase 2 total trial costs.
  • Review 9 Phase 2 oncology trial profiles detailing:
    • Trial background
    • Budget
    • Staffing
    • Patient enrollment
    • Duration



Chapter Data

14 charts detailing key trial cost, staffing and efficiency metrics for surveyed Phase 2 trials.

  • Total trial costs (by trial)
  • Percentage of costs outsourced (by trial)
  • Average planned and actual patient enrollment
  • Planned and actual patient enrollment (by trial)
  • Correlation between Phase 2 patient enrollment and trial costs
  • Cost per patient (by trial)
  • Actual duration (by trial)
  • Correlation between Phase 2 trial duration and trial costs
  • Cost per patient per month (by trial)
  • Average Phase 2 staffing (by position)
    • CRAs/monitors
    • Trial managers
    • Clinical program directors/leaders
    • Data management
    • Medical writing
    • Biostatistics/bioanalytics
    • Regulatory
    • Clinical quality assurance
    • Clinical trial supplies (CTS)
    • Chemistry, manufacturing and control (CMC)
    • Contract management
    • Drug safety
  • Number of patients per CRA (by trial)
  • Number of sites (by trial)
  • Number of patients per site (by trial)
  • Number of sites per CRA (by trial)

9 Phase 2 trial case studies showing:

  • Trial background and budget
  • Cost metrics and staffing
  • Duration and enrollment

 

Chapter 3: Phase 3 Oncology Trials

Chapter Benefits

  • Compare key cost metrics across multiple Phase 3 trials, including:
    • Total trial cost
    • Percentage of costs outsourced
    • Cost per patient
    • Cost per patient per month
  • Prepare for the highest clinical investments — financial, staffing and
  • time — in Phase 3 trials.
  • Examine staffing Phase 3 staffing trends across 12 key functions.
    • Compare how late-stage trials leverage outsourcing to maintain trial sites.
    • See how the increased need for Phase 3 patients and trial sites impact efficiency metrics including patients per CRA and sites per CRA.
  • Measure the impact of key cost-drivers — patient enrollment and trial duration — on Phase 3 trial costs.
  • Review 9 Phase 3 oncology trial profiles detailing:
    • Trial background
    • Budget
    • Staffing
    • Patient enrollment
    • Duration



Chapter Data

14 charts detailing key trial cost, staffing and efficiency metrics for surveyed Phase 3 trials.

  • Total trial costs (by trial)
  • Percentage of costs outsourced (by trial)
  • Average planned and actual patient enrollment (by trial)
  • Correlation between Phase 3 patient enrollment and trial costs
  • Cost per patient (by trial)
  • Actual duration (by trial)
  • Correlation between Phase 3 trial duration and trial costs
  • Phase 3 cost per patient per month (by trial)
  • Average Phase 3 staffing (by position)
    • CRAs/monitors
    • Trial managers
    • Clinical program directors/leaders
    • Data management
    • Medical writing
    • Biostatistics/bioanalytics
    • Regulatory
    • Clinical quality assurance
    • Clinical trial supplies (CTS)
    • Chemistry, manufacturing and control (CMC)
    • Contract management
    • Drug safety
  • Number of patients per CRA (by trial)
  • Number of sites (by trial)
  • Number of patients per site (by trial)
  • Number of sites per CRA (by trial)

9 Phase 3 case studies showing:

  • Trial background and budget
  • Cost metrics and staffing
  • Duration and enrollment

Excerpt from Oncology Clinical Trial Report

 

The following is a key finding excerpted from the full report's executive summary:

Plan for Longer Trial Durations as Clinical Development Progresses

According to Figure E.3 [Figure included in full report], profiled trials in Phases 1 and 2 experienced similar rates of duration — on average 27.5 and 26.1 months, respectively.  These early phase trials also reported maximum trial durations of between 48 and 50 months.  By comparison, the average length of Phase 3 trials totaled 41.3 months, and the longest Phase 3 trial topped 81 months.  Typically, as clinical trials evolve from Phase 1 to Phase 3, companies incur trials with longer durations and larger differentials between targeted and enrolled patient numbers.  Across all clinical phases, this study identified two key determinants of trial length:

  • Degree of difficulty of trial-specific patient recruitment
  • Number of patient visits required by trial

 

In many cases, patient recruitment difficulties delay trials as companies struggle to meet their enrollment targets.  If a particular therapeutic area is already competing with a number of companies performing clinical trials, enrolling patients becomes even more challenging.  Depending on a specific oncology area’s competitiveness, some targeted patients may already be participating in other investigative trials.  In regions with more available treatment options, patients may favor current standard of care regimens above investigative trials.  Patient recruitment may be less challenging in regions where clinical trials represent one of few cost-efficient treatment options available for afflicted patients.

Phase 1 trials averaged a 7.8-month delay between projected and actual end dates.  Phase 2 trials reported an average of a 5.1-month delay and Phase 3 reported a 6.4-month delay.  Companies may have a harder time developing participant criteria during Phase 1 — explaining patient recruitment difficulties present during some of the profiled Phase 1 trials.  For example, Trial C extended its timeline well-beyond its projected end date.  The trial did not achieve 50% patient enrollment until the trial was 42 months in — 20 months longer than forecasted.  Even upon trial completion, the trial failed to meet its target participation, falling 9% short of its patient enrollment goal.

By the time a compound enters Phase 2 investigative trials, companies begin better streamlining their enrollment criteria.  Although only logging 140 of its desired 172 participants, the longest running Phase 2 trial — Trial R — only superseded its projected end date by three months.  The trial dedicated its additional time toward achieving 50% patient enrollment.

The number of patient visits required by investigative trials also influences the duration of profiled trials across Phases 1, 2 and 3.  For trials that require multiple patient visits, the amount of time trial participants must wait before undergoing additional monitored visits may skew the actual trial duration.  In each of the three clinical phases, the longest profiled trial required a set number of patient visits.  Trial C (Phase 1) required 10 visits, Trial R (Phase 2) required 9 and Trial W (Phase 3) required 25 visits.

The two profiled Phase 1 trials that provided a required number of patient visits — C with 10 and G with 15 visits — each took longer than the forecasted average among Phase 1 trials (31.6 months).  Two of the Phase 2 trials that required multiple patient visits spanned beyond the average duration of 27.1 months.  Trial P, the single Phase 2 trial that required double-digit patient visits (10) but fell below the average duration — lasting 22 months — maintained sites in the US and in emerging Asian markets.  Because Trial P operated across 40 sites — many of which were located in regions with large treatment naïve populations including Malaysia, Thailand and China — it did not have to contend with the added difficulty of patient recruitment.  Each of the Phase 3 trials that required any number of patient visits lasted longer than the average Phase 3 duration of 41.3 months.