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Consider two studies that both achieve their enrollment targets and meet sponsor expectations. On paper, they appear equally successful. Yet one study required extensive participant screening, multiple protocol amendments, increased coordination across departments, and significant effort from study teams. The other progressed largely as planned.
The outcome is the same. The work required to achieve it is not. And because workload ultimately drives cost, understanding those differences becomes critical to understanding the true cost of conducting research.
Most research organizations have no shortage of performance metrics. Enrollment rates, activation timelines, participant retention, protocol deviations, and financial measures all provide valuable insight into how research programs are performing. Yet these measures do not always answer a fundamental question, understanding not all trials require the same effort to achieve the same result: What did it actually cost to achieve those results?
As clinical trials become more complex and research organizations face ongoing pressure to do more with limited resources, the relationship between workload, cost, and performance becomes increasingly important. A clearer picture starts with identifying where workload occurs and how it affects cost.
Understanding the Relationship Between Workload, Cost, and Performance
Budgets and financial reports help organizations evaluate financial performance, but they do not always explain the operational factors driving those results.
For many organizations, significant workload arises from activities such as:
- Screening participants who never enroll
- Implementing protocol amendments
- Coordinating with sponsors and ancillary departments
- Maintaining regulatory documentation and study records
- Addressing operational issues that never appear in a dashboard or executive report
Individually, these activities may seem routine. Collectively, they can represent a significant portion of the workload required to conduct a study and, ultimately, a significant portion of the cost.
What Research Leaders Can Do to Understand the True Cost of Research
Studies that produce similar outcomes may require dramatically different levels of staff time, operational support, and institutional investment. Understanding those differences is essential to developing realistic budgets, allocating resources, and sustaining research programs as protocols become more complex.
Organizations do not need to track every minute of staff time to better understand the relationship between workload, cost, and performance. They can begin with:
- Understanding the true cost of achieving first-patient first visit and enrollment goals across different study types and therapeutic areas
- Quantifying how protocol complexity drives resource requirements, timelines, and study execution costs
- Evaluating whether study funding adequately supports the effort required to deliver expected study outcomes
- Aligning staffing investments with the workload necessary to meet activation and enrollment performance targets
- Enabling data-driven portfolio decisions based on anticipated effort, cost, feasibility, and expected study value
Organizations that understand the relationship between workload, cost, and performance are better positioned to make informed decisions about budgeting, staffing, study selection, and portfolio growth.
The most successful research organizations are not those that simply achieve their targets, but those that understand the true cost of achieving them.
Authored by Shreya Singh, Manager, Huron Consulting Group
