Optimizing data integration in trials that use EHR data: lessons learned from a multi-center randomized clinical trial.

ABSTRACT:

Background

Despite great promise, trials that ascertain patient clinical data from electronic health records (EHR), referred to here as "EHR-sourced" trials, are limited by uncertainty about how existing trial sites and infrastructure can be best used to operationalize study goals. Evidence is needed to support the practical use of EHRs in contemporary clinical trial settings.

Main text

We describe a demonstration project that used EHR data to complement data collected for a contemporary multi-center pharmaceutical industry outcomes trial, and how a central coordinating center supported participating sites through the technical, governance, and operational aspects of this type of activity. We discuss operational considerations related to site selection, data extraction, site

SUBMITTER: Raman SR 

PROVIDER: S-EPMC10474626 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature