Applying the OMOP Common Data Model to Facilitate Benefit-Risk Assessments of Medicinal Products Using Real-World Data from Singapore and South Korea.

ABSTRACT:

Objectives

The aim of this study was to characterize the benefits of converting Electronic Medical Records (EMRs) to a common data model (CDM) and to assess the potential of CDM-converted data to rapidly generate insights for benefit-risk assessments in post-market regulatory evaluation and decisions.

Methods

EMRs from January 2013 to December 2016 were mapped onto the Observational Medical Outcomes Partnership-CDM (OMOP-CDM) schema. Vocabulary mappings were applied to convert source data values into OMOP-CDM-endorsed terminologies. Existing analytic codes used in a prior OMOP-CDM drug utilization study were modified to conduct an illustrative analysis of oral anticoagulants used for atrial fibrillation in Singapore and South Korea, resembling a typical benefit-risk assessme

SUBMITTER: Tan HX 

PROVIDER: S-EPMC9117808 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature