Abstract 06: Streamlining data management for clinical trials

Abstract

Abstract The purpose of this study is to answer the FDA’s call to action for new research paradigms that rely on real-world data (RWD) to increase the efficiency of clinical trials and to conduct research using an approach that is less disruptive to the patient-provider clinical care setting. With the expansion of electronic health record (EHR) vendor structured data models, clinical study data can be directly captured using the patient’s EHR data as documented in the health care organization’s (HCOs) electronic medical record (EMR) system(s) and other electronic data sources (eSources). In partnership with HCOs, the Optum Digital Research Network is conducting a pilot to enable effective RWD extraction, normalization, and transcription from EMRs and other eSource to a read-only electronic data capture (EDC) system, effectively eliminating the need for duplicative data entry during the study. Optum is developing custom database queries to extract structured EMR data (including demographics, medications, labs, vitals, and encounters) from the respective domains of each EMR into a staging database. The raw data are then curated, normalized, and mapped into a common data model study database. In this case, the Observational Medical Outcomes Partnership (OMOP) data standard is employed as the clinical data management (CDM) model. The curated data are then mapped to Clinical Data Acquisition Standards Harmonization (CDASH) variables and transmitted to an EDC system using the EDC vendor’s application programming interface (API). The entire process is scheduled on a daily cadence (removing any duplicate data) to capture any updated visit information, medications, labs, or vitals. The EDC form fields are read-only. If there is a discrepancy or query, sites are notified requesting to confirm or correct their EHR data, which may result in an update to the respective read-only EDC form fields. Through this pilot project, Optum’s successful transfer of structured EMR data to a read-only EDC system has substantial implications for clinical research. Using data and technology, this methodology is projected to improve the efficiency (and lower costs) of clinical trials while minimizing the burden on HCOs. Citation Format: Brook Norris, Lauren Neighbors, Lucas Wale. Streamlining data management for clinical trials [abstract]. In: Proceedings of the AACR Special Conference on Advancing Precision Medicine Drug Development: Incorporation of Real-World Data and Other Novel Strategies; Jan 9-12, 2020; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(12_Suppl_1):Abstract nr 06.