OBJECTIVES: Due to backlogs created by the COVID-19 pandemic on patient healthcare delivery coupled with an increase in the number of studies and breadth and depth of research questions, there are significant challenges with the timely conduct of real-world data (RWD) studies relying on data abstraction from electronic health records (EHRs). Many healthcare providers (HCPs) are increasingly unable to participate in RWD studies due to time and resource constraints and the need to prioritize clinical work and trials. Therefore, identifying robust solutions to facilitate and streamline HCP participation in RWD studies and address broad and diverse stakeholder research needs is of paramount importance to future direction and success of RWD research.

METHODS: Critical review of electronic data capture (EDC) technology (EHR2EDC), which pushes data directly from site EHRs to study EDC systems enabling robust data accrual while reducing site staff workload compared to traditional abstraction methods such as manual chart reviews.

RESULTS: While EHR2EDC technology is validated and compliant with country specific data privacy and handling requirements and can significantly reduce workload, the adoption has been sporadic and is not standard practice. Key barriers to mainstream EHR2EDC adoption have included: limited technical understanding and perceived concerns over patient privacy/data sharing by HCP/stakeholders leading to hesitancy, lack of standardized guidance for technology incorporation into studies, and site capacity hindering timely initial set-up/configuration. Even though these barriers are not insignificant, they can be successfully overcome by educating HCPs/stakeholders, putting clear guidance in place for use of EHR2EDC technology, and slowly integrating such technologies into RWD studies. Trust and confidence in new data extraction technologies will only be possible through collaboration, implementation and adjusting overtime as needed.

CONCLUSIONS: While there are key considerations for the successful incorporation of EHR2EDC technology in RWD studies, the benefits of doing so will outweigh the risks in the long run.