A new approach to managing workloads for clinical researchers at Fox Chase Cancer Center has been found effective in reducing workload imbalances and enhancing phase 1 clinical programs. The study’s results were presented at the Association of American Cancer Institutes’ Clinical Research Innovation Annual Meeting.
Phase 1 clinical trials mark the initial stage of testing potential new drugs in humans. At Fox Chase, these trials are crucial for early clinical trial development, where researchers evaluate new treatments for safety and appropriate dosage.
Shannon Fabrie, BS, project lead and Disease Site Research Manager for phase 1 trials at Fox Chase, explained the motivation behind the study: “This study came about because there didn’t seem to be a very robust system on how we were assigning studies and how we were assessing workload per study.” She noted that existing systems did not effectively categorize phase 1 studies.
Fabrie developed the Oncology – Phase 1 Acuity Scoring System (O-PASS) to improve workload distribution and expand patient access to clinical trials. O-PASS employs a rubric with 20 criteria on a standardized scoresheet to evaluate each phase 1 trial. This scoresheet assigns weighted scores that help distribute studies among research coordinators based on estimated workloads.
“Using O-PASS allows me as a manager to clearly compare the workloads of my clinical research coordinators and clinical research nurses so that I may assess how best to balance the portfolio,” said Fabrie. She added that it also enables her to assign high acuity studies to more experienced team members.
In addition, Fabrie has provided her team with assessment questionnaires to gauge whether this method improved their work-life balance and whether workloads were fair. “The feedback has been really positive so far,” she reported. Plans include ongoing assessments every six months and potentially expanding O-PASS use to data specialists.
The AACI CRI meeting took place from June 23-25 in Chicago.
