Transforming data management in clinical trials: Uncovering CRC pain points through user research.

Abstract

e21001 Background: Clinical trial timelines are significantly influenced by the efficiency of data transfer from sites’ Electronic Health Records (EHRs) to sponsors’ Electronic Database Capture (EDC) systems. However, optimizing workflows and tools to assist Clinical Research Coordinators (CRCs) in this process remains underprioritized. Previous studies show that data abstraction roles turnover at rates up to 40%, further exacerbating data transfer delays and escalating costs. Methods: The objective of the study was to investigate shared CRC challenges for the data abstraction process to establish a common understanding of CRC challenges. Forty remote, 60-minute, semi-structured interviews were conducted between 01/22 to 11/24 across six academic cancer centers in the US (4) and the UK (2). Participants included were responsible for transferring data from EHRs to EDCs for clinical trials. To analyze the qualitative data gathered, ground theory-based thematic coding was employed using Dovetail software. Results: Key pain points for CRCs identified across institutions include: Labor-intensive data abstraction: Time-consuming processes to extract data from unstructured EHR notes (e.g., medical history, QoL surveys) and manually enter dozens of data points (e.g., labs, concomitant medications) per cycle into EDCs. A CRC typically manages 5–8 protocols simultaneously. Disjointed system workflow: Navigating multiple EHR tabs and systems, particularly when abstracting PI-verified data like Adverse Events, disrupts workflow efficiency. Five of six sites used the same EHR vendor. Task and query management challenges: Tracking and prioritization of tasks related to data entry, administrative, and queries increase burden. Data gaps from external institutions: Missing or incomplete external records often require follow-up with other institutions. Upstream data reconciliation: Incomplete data capture frequently necessitates additional input or clarification from PIs. Limitations in CRF design: Sponsor-designed case report forms (CRFs) in EDCs often lack CRC input, leading to inefficiencies and excessive auto-queries. Variations in workflows were largely driven by differences in system architectures, EHR configurations, and whether templated data capture processes were in place. Conclusions: Current systems are not optimized for CRC workflows for efficient data abstraction. Addressing these pain points through collaboration between sites and sponsors could improve operational efficiency, shorten study timelines, and reduce costs through fewer data inconsistencies, decreased query resolution volume, and mitigated turnover-related expenses. Establishing integrated systems and workflows will drive systemic improvements in clinical trial operations, advance the pace of oncology research and ultimately improve the quality of patient care.