The UF Health Cancer Institute’s Clinical Research Office has developed and implemented a practical tool that supports data-driven, endpoint-focused clinical trial design. The work won first place at the 18th annual Association of American Cancer Institutes (AACI) Clinical Research Innovation Meeting, held June 23-25 in Chicago, and could serve as a model for enhancing clinical trial operations at other National Cancer Institute-designated cancer centers.
“We wanted to help investigators make more intentional data collection decisions at the protocol design stage,” said Nina McGrew, M.S.N., RN, ACRP-CP, assistant director of project management and network operations and the abstract’s first author. “We built a standardized tool to close that gap prospectively and measured whether using the tool at the protocol design stage produced a meaningful improvement.”
The team piloted the method, called the Data Alignment Assessment Tool (DAAT), and found it led to a 33% reduction in nonessential data and 36% increase in endpoint-aligned data. That showed it’s feasible to reduce nonessential data collection while maintaining regulatory compliance.
“It was pretty significant,” McGrew said. “The tool asks investigators to score each data point based on whether it supports a primary, secondary, exploratory or nonessential endpoint, so it makes you very intentional and focused about what you’re collecting. This can dramatically reduce the unnecessary data burden on the backend for our clinical research teams.”
The project began after the Cancer Institute’s Compliance Group highlighted an emerging trend in clinical research of endpoint misalignment in clinical trial protocols. A major catalyst came when Alison Ivey, D.H.A., M.S., M.B.A., RN, OCN, CCRP, made a startling discovery in the literature: Up to 40% of data collected in academic clinical trials is not connected to primary or secondary endpoints.
The team plans to refine the tool and implement it across the institute’s investigator-initiated trial (IIT) portfolio. They will assess its impact on data volume and staff efficiency in a range of oncology trial types, phases and disease sites. It may also be integrated as a standard component of the Project Management Office’s protocol development process and IIT Think Tank concept review.
“Ultimately, we hope there is broader dissemination across the NCI cancer center network,” McGrew said. “We want it to be a shareable, reproducible quality improvement tool that enhances data quality, reduces staff workload and improves the feasibility and efficiency of IITs.”
Coauthors on the abstract include Lydia Napier, a clinical research coordinator in the Solid Tumor Unit who dove into the work with dedication as a Clinical Research Office intern; Shannon Alford, M.P.H., CCRC, manager of the Project Management Office who partnered with the PMO team and helped champion the process; and the institute’s leadership team, including Thomas George, M.D., FACP, FASCO, interim director, Alison Ivey, D.H.A., M.S., M.B.A., RN, OCN, CCRP, chief administrative officer, Paul Crispen, M.D., associate director for clinical research, and Erin Monari, Ph.D., administrative director of the Clinical Research Office.
“Winning first place at AACI is a tremendous honor and it belongs to this entire team,” McGrew said.
