Clinical trials are hard. They are complex, expensive and time consuming. During this year’s 8th Annual AACI-CRI meeting, opening sessions focused on tackling these issues by streamlining clinical trial operations from two perspectives. The first was the incorporation of a clinical trial feasibility committee. The second session focused on assessing workflow.
The scope of these internal committees are to review the logistics of clinical trials with the purpose of addressing any roadblocks that may affect study activation and execution. Three institutions (University of Kansas Cancer Center, Cancer Therapy and Research Center at the University of Texas Health Science Center, and Huntsman Cancer Institute) discussed their committees and processes.
All centers incorporated the committee prior to scientific committee review. These committees are made up of leadership from the different stakeholders in clinical research (e.g. lab, clinical trials office, data management) to ensure all impacted core services are able to provide input on the trial. In alignment with their scope, they meet weekly to minimize the impact on the study activation process. However, the centers track study activation timelines starting post-feasibility committee, so the impact on the overall activation timeline is unknown. A number of documents, including the protocol, lab manual, pharmacy information, etc. are required to be submitted so the committee can have a complete view of the trial needs. One benefit of doing such a thorough review prior to study activation is that any inconsistencies, errors or vague instructions can be corrected by the sponsor prior to data collection.
Each center stated that very few studies are disapproved to the point where they are discontinued. As the purpose of the committee is to ensure the study can be run efficiently and effectively, most studies are revised to improve workflow. Comments and reviews from the committee are included with the scientific review committee application.
Feasibility committees are not unique to these three institutions. A show of hands revealed that about one-third of attendees had a feasibility committee process.
ASCO, through the ASCO Research Community Forum and in partnership with community based systems, have adapted the Wichita CCOP protocol acuity tool to calculate staff workload and protocol acuity. The goals of the tool are to be 1) simple; 2) reproducible; and 3) usable in the long term. It’s purpose is to help research sites assess staff workload based on the complexity of research protocols and the number of enrolled subjects and their stage of participation.
The tool was tested with 51 community-based oncology research programs from May through November 2013. These programs varied in size and institution type. In the six months of data collection, a large amount of information was obtained from the sites that covered over 900 unique protocols from 165 unique sponsors. The result was that acuity scores could be calculated for projects, with treatment trials having a higher acuity than cancer control and prevention trials. Studies with subjects on study had a higher acuity than those with subjects only on follow up. Industry trials had a higher acuity score than other types of trials. The tool is available for use and has been downloaded by over 200 centers worldwide.
Building on the workload tool, Huntsman presented their tool, CRANIUM, which uses data collected from OnCore® Enterprise Research and calculates clinical research coordinator workload. The tool has been statistically validated and provides objective data in an automated method. They use it to find the “Golden Zone” for staff workload and quantitatively balance protocol assignments to CRCs.
Clinical trial complexity is not going away, and attendees at the AACI CRI conference are taking the issue head-on to ensure the integrity of clinical trials execution, staff workload and meeting sponsor/NCI requirements.