Lesley Curtis, PhD, and Emily O’Brien, PhD, Department of Population Sciences, Duke Clinical Research Institute
Leveraging Electronic Health Data in a Multinational Clinical Trial: Early Learnings from the HARMONY-Outcomes EHR Ancillary Study
Pragmatic clinical trial; Clinical research; EHR; Electronic Health Data
- Electronic health data changes the conduct of clinical trials through less data work at local sites and an improved ability to find participants
- HARMONY-Outcomes explores whether EHRs are fit to facilitate clinical research recruitment and be used for endpoints
- Study-specific queries of EHRs yield the highest number of potentially eligible participants, over fliers, ads, and other traditional methods
- DataMart allows sites to query and generate datasets that DCRI national partners can share and compare across secure servers
- HARMONY-Outcomes early lessons include governance and process issues, and major disparities in access to EHR data across sites
Although recruitment was the main focus of this ancillary study, consideration was given to conducting a parallel evaluation of using baseline covariate assessment and clinical endpoint ascertainment.
When linking to external sources (insurance claims, national hospital register) to ascertain outcomes, one is able to benchmark from one system to another to assess completeness of ascertainment.
Escalating capacity within sites over time is crucial to establishing data banks and creating faster access to data. There are not too many technical barriers at sites, but there needs to be a business case for refreshing data and seeing the value of current data.
An important consideration is people who receive one type of care in one hospital system and another type of care in another system, and making sure to capture all data.
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