Clinical Development and Trial Operations (PH192)

Protocol Design and Cost Per Patient Benchmarks
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Published 2013
221 Pages
500+ Metrics
147 Charts and Diagrams

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.

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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?

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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.

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.
  • Implement decentralized structures to enable clinical teams to focus on specific therapeutic areas.
  • Identify which functions to recruit to provide 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: Refining Clinical Teams’ Staffing and Outsourcing Decision Making

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

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

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 stages trials become delayed — and learn other teams keep projects on track.
  • Save time and money by investing upfront and planning longer to
  • Prevent expensive delays down the road.
  • Learn new tactics for understanding patient motivation — essential to 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

Clinical Operations Report Sample

The following excerpt is taken from Chapter 2, “Clinical Trial
Staffing Benchmarks.” It outlines the information contained
within this section of the report. For complete access to
detailed benchmarks, please purchase the full report.

Staffing Levels for Development Phases

This section includes detailed staffing benchmarks for each of the five phases of
clinical trials: Phase 1, Phase 2, Phase 3a, Phase 3b and Phase 4. In addition,
the staffing data included in this section are broken down into 12 occupational
categories. Each represents a unique role in the clinical development process.

Although many of these development functions are members of trial teams at
most companies, not all companies analyzed for this study organize their clinical
development teams in the same manner. As such, some functions — such as
clinical trial supplies, chemistry manufacturing and controls (CMC), and drug
safety — often play a supporting role in the clinical development process even
though they may not sit on trial teams. In each category, the data tables present
staffing metrics for both in-house and outsourced staff. These are the 12

  • CRAs/Monitors
  • Trial Managers
  • Vice Presidents, Clinical Program Directors, and other such therapeutic
    area supervisors
  • Data Management
  • Medical Writing
  • Biostatistics/Bioanalytics
  • Regulatory
  • Clinical Quality Assurance (QA)
  • Clinical Trial Supplies
  • Chemistry Manufacturing and Controls (CMC)
  • Contract Management
  • Drug Safety

The data contained in each of the 12 categories represent peak staffing levels for
the development phase, as measured in full-time equivalents (FTEs). FTEs do not
always correspond to the number of people actually working on a certain task.
One FTE, for example, may equate to two people spending 50% of their time each
on the task.

The data tables [available in the full report] present actual staffing levels
for clinical trials in each phase. Each staffing table includes the following
information about each trial:

  • Therapeutic area
  • Study location(s)
  • Number of patients enrolled
  • Number of investigator sites

These four factors act as important guides to enable readers to compare staffing
trends between trials.

Clinical Trial Staffing: Phase 1

Data in the figures from Chapter 2 [available in the full report]
represent nine Phase 1 clinical studies from these therapeutic areas:

  • Cardiovascular Disease
  • Central Nervous System/Neurology
  • Diabetes
  • Endocrinology
  • Oncology

Overall, Phase 1 clinical trials employ the fewest number of FTEs and outsource
the lowest percentage of staff. Figure 2.5 shows this clearly: the data show that
the largest staffing categories are CRA/monitor and data management, but they
still only account for an average of 3.1 FTEs and 2.5 FTEs, respectively. With an
average of 3.1 CRAs per trial, Phase 1 ranks lowest among all other phases.

The following excerpt is taken from Chapter 4, “Adaptive Clinical Trial Design.”
The full chapter provides a comprehensive analysis of adaptive design. It
includes a detailed discussion on the FDA’s new guidance, as well as
benchmarks showing adaptive design usage and its impact on time and cost.

Reaction to FDA Guidance

On its face, the guidance provides a cautious endorsement of adaptive design
as a method for accelerating the development process and increasing the
efficiency of clinical trials. However, the reality — as shown in Figure 4.3 [available in the full report] — is that it is used infrequently at all stages of clinical
development, especially in critical Phase 3 trials. Figure 4.4 shows survey
respondents’ perceptions of the likelihood of introducing adaptive design into
trials at various phases of development, rating each on a scale of one to five
(with five representing very likely). Respondents identified Phase 2 as the most
probable place to use adaptive design, followed by Phase 3b. During interviews,
industry experts noted that Phase 3b trials, typically follow-ups to already
successful confirmatory studies, are ripe for adaptive design because companies
are pushing to get an approval they are confident will occur, and time- and costsaving
tactics are at a premium.

The question of when pharma will begin to put adaptive design to use in Phase 3a
trials more frequently will hinge on the success — or failure — of some of the early
adopters of the technique. Until a high-profile drug approval is won with adaptive
design incorporated into the Phase 3 protocol, trepidation will remain.
“I think the FDA needs to clarify what their position is. Because in spite of what
is in the guidance...the reviewing divisions have made it clear that they’re still
uncomfortable with anything that happens to the data that might compromise
the integrity of the data or introduce bias,” said the regulatory affairs manager at
Company C.

He continued:

"So I think frankly that a number of sponsors would entertain the idea of doing adaptive
design in Phase 3 studies, particularly if you’re doing the so-called seamless Phase 2-3.
They’re concerned that at the end of the day, the reviewers are going to come back and
say you unblinded the data too early, the study wasn’t over, etc., so there’s a chance that
bias has been introduced and you’re going to have to take either a statistical hit or do
something that will compromise your ability to gain an approval easily. I think it really is a
question to a certain extent of mixed messages."

The statistical review personnel at the FDA view adaptive design as a major technical
advance, but long-tenured regulatory personnel have a less favorable view of the new
technology and are less likely to fully support it. In response, clinical directors are
reluctant to take a perceived risk with adaptive trial designs that may not serve the
company’s goal of getting a drug to market as quickly as possible.

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)