Many research institutions face the challenge of effectively allocating resources for clinical trial activity on a daily basis. Often, the task is conducted without factual, data-driven assessments of the staff effort required for study activities. The use of rough estimates may result in wasted staff time or inadequate support for trial activities. Additionally, institutions may not be able to effectively negotiate trial budgets without proper insight and statistical support of the demands placed upon staff during a trial.
This is the story of how Indiana University Simon Cancer Center (IUSCC) set out to find a better way to manage staff workload and negotiate trial budgets.
The experience at Indiana University Simon Cancer Center
It began when IUSCC participated on a collaborative project in which leading research institutions each measured trial activity, such as the time required to open a new study and the time to begin accruing subjects. In this collaboration, facilitated by Forte Research Systems, the participating centers recognized an opportunity to better track site work effort related to trial activity and identify where processes might be improved to shorten trial lifecycle times.
“We wanted to identify the tasks required to open and manage, as well as close, any given trial. From there, we wanted to identify how much time is spent on certain tasks and who is performing them,” explained Kerry Bridges, Administrator at IUSCC Clinical Research Office. “How long does it take to conduct a study from study start-up, active status, follow-up, and close-out and what variables affect that effort; i.e. sponsor type, Phase, CRO-managed?”
“Along those lines, there were additional questions we set out to answer,” Bridges said. “Are we budgeting appropriately? Do I have enough resources dedicated to these efforts? Can we determine a reasonable workload in terms of capacity and set some benchmarks?”
With the goals set for the collaboration, IUSCC worked with the other participating institutions to define key stages to track and delineate effort. Start-up, Active, Follow-up and Close-out were agreed upon.
Additional categories or “buckets” were defined throughout the project. These included:
- Data management
- Clinical Activity/Coordination
Tasks within a category, such as amendments, patient care, vendor inquiries, SAE management, and contract negotiation, were also specified.
The research effort tracking tool was developed by Forte Research Systems as an application made available through the internet. During the pilot project, users would log in to a web portal in order to log and track activity in the Effort Tracking tool.
Effort tracking in OnCore Enterprise Research System
Since the spring of 2012, the research effort tracking functionality has been integrated into Forte’s OnCore Enterprise Research system. Using built-in functionality in the OnCore system means recording activity becomes a natural part of the workflow for staff members.
To learn the results of Indiana University’s pilot project, including how the resulting data had a positive impact on budgeting for sponsored trials, download the case study, “Indiana University Effectively Manages Staff Workloads; Streamlines Budget Negotiation.”