Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

Abstract

Background: Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems.

Methods: Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project.

Results: The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records.

Conclusions: Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

Keywords: Clinical trials; Common data elements; Data quality; Electronic health records; Metadata; Secondary use.

Fig. 1

Process steps to create the data inventory for common data elements in clinical trials and their frequency of documentation in European EHR systems. First, clinical trials were collected and imported into the trial master database (TMDB). Then forms were categorized into domains, and all data elements were normalized. Top data elements per form domain were determined. Top form domains were reviewed by EFPIA partners. Afterwards, at a face-to-face meeting all elements were jointly discussed with academia and pharmaceutical partners. Finally, clinical sites identified element presence and performed data exports to determine the frequency of documentation

Fig. 2

Extract from the entire data inventory for clinical trial execution and SAE reporting. On the left-hand side the data elements and their form domains are listed followed by the number of sites in which they occur and the sites availability. Site 1 and 2 used their data warehouse (DWH) for element identification and exports

Fig. 3

Common data elements for the reporting of SAEs. More than half of the data exporting sites have no SAE documentation available in their EHRs. This refers to the items ‘seriousness’, ‘action taken’, and ‘autopsy report in case of death’. Some sites have few data elements available but unclear whether data values are present apart from one where no data has been captured so far