ENHANCING REAL-WORLD DATA (RWD) QUALITY: IMPLEMENTATION OF REGULATORY DATA QUALITY FRAMEWORK WITHIN A LARGE US ONCOLOGY ELECTRONIC HEALTH RECORD (EHR)-DERIVED DATABASE
Author(s)
Zhaohui Su, PhD, Jessica Paulus, ScD, Kat Aguilar, MPH, PhD(c), Aniketh Talwai, MBA, Saamir Pasha, MPH, Jay hugalavalli, BS, Jennifer Frytak, PhD, Amy K. O'Sullivan, PhD, Janet Espirito, PharmD;
Ontada, Boston, MA, USA
Ontada, Boston, MA, USA
OBJECTIVES: The FDA-led QCARD Initiative and European Medicines Agency (EMA)’s Data Quality Framework (DQF) provide structured guidance to advance RWD quality. This study aimed to present the approaches and results of applying QCARD and DQF to the ON.Genuity platform, which integrates iKnowMed EHR and supplementary data sources.
METHODS: QCARD and DQF principles were applied by standardizing structured and unstructured data following Fast Healthcare Interoperability Resources (FHIR) and Minimal Common Oncology Data Elements (mCODE). Metadata and lineage documentation were used to support traceability and transparency. External validation was performed using the US National Death Index (NDI). Automated checks for reliability and fit-for-use were implemented in a cohort of multiple myeloma (MM) patients diagnosed between 2018 and 2024.
RESULTS: The On.Genuity platform contains more than 250 standardized variables over 20 clinical domains across 67 standardized cancer types. De-identified near real-time RWD since 2010 were available for approximately 4M patients from 700+ US community oncology clinics. Traceability and conformance were attained 100% by established audit trail and following FHIR and mCODE. External validity analyses demonstrated consistency between the mortality data and the NDI, with a median overall survival of the same magnitude (p = 0.9). The reliability and fit-for-purpose analysis included 4,578 MM patients with a median (IQR) follow-up of 24.5 (IQR 13.4, 43.2) months. Data completeness exceeded 90% for demographics, disease characteristics, medication history, biomarkers, and other clinical variables. Among 26 standard edit checks, 16 returned no findings, indicating complete reliability. Of the remaining 10, only 2 identified data discrepancies affecting more than 1% of patients, necessitating additional expert review.
CONCLUSIONS: Implementation of the QCARD and DQF within the ON.Genuity platform introduces a process for generating high-quality RWD in oncology. This research contributes to streamlining regulatory submissions, promoting the use of RWD in in evidence-based decision-making, and may serve as a reference for other therapeutic areas.
METHODS: QCARD and DQF principles were applied by standardizing structured and unstructured data following Fast Healthcare Interoperability Resources (FHIR) and Minimal Common Oncology Data Elements (mCODE). Metadata and lineage documentation were used to support traceability and transparency. External validation was performed using the US National Death Index (NDI). Automated checks for reliability and fit-for-use were implemented in a cohort of multiple myeloma (MM) patients diagnosed between 2018 and 2024.
RESULTS: The On.Genuity platform contains more than 250 standardized variables over 20 clinical domains across 67 standardized cancer types. De-identified near real-time RWD since 2010 were available for approximately 4M patients from 700+ US community oncology clinics. Traceability and conformance were attained 100% by established audit trail and following FHIR and mCODE. External validity analyses demonstrated consistency between the mortality data and the NDI, with a median overall survival of the same magnitude (p = 0.9). The reliability and fit-for-purpose analysis included 4,578 MM patients with a median (IQR) follow-up of 24.5 (IQR 13.4, 43.2) months. Data completeness exceeded 90% for demographics, disease characteristics, medication history, biomarkers, and other clinical variables. Among 26 standard edit checks, 16 returned no findings, indicating complete reliability. Of the remaining 10, only 2 identified data discrepancies affecting more than 1% of patients, necessitating additional expert review.
CONCLUSIONS: Implementation of the QCARD and DQF within the ON.Genuity platform introduces a process for generating high-quality RWD in oncology. This research contributes to streamlining regulatory submissions, promoting the use of RWD in in evidence-based decision-making, and may serve as a reference for other therapeutic areas.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PT3
Topic
Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance, Reproducibility & Replicability
Disease
SDC: Oncology