|147 Charts and Diagrams|
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.
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.
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).
41 charts detailing CRA staffing and outsourcing trials. Charts include patients per CRA and sites per CRA for trials in 16 therapeutic areas.
Trial Costs Outsourced
14 charts detailing protocol development planning and site management:
15 charts detailing trial duration, delays, number of enrolled patients and number of months to achieve trial milestones.
62 charts detailing clinical trial costs, including per-patient cost and total trial cost across phases for 25 therapeutic areas.
Therapeutic Areas Covered:
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.
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
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:
These four factors act as important guides to enable readers to compare staffing
trends between trials.
Data in the figures from Chapter 2 [available in the full report]
represent nine Phase 1 clinical studies from these therapeutic areas:
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.
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
"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.
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:
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)