By Deborah Borfitz 

March 24, 2021 | TransCelerate’s eSource initiative supporting decentralized clinical trials aims to add efficiency to the clinical research process by facilitating the exchange of data between sites and sponsors and “filling the gaps” in the primary data interchange standards governing electronic health record (EHR) systems, according to Joe Dustin, head of clinical innovation at Bristol Myers Squibb. The benefits of eSource include not just faster data capture and changing the workflow and burden on sites but broadening remote data access for improved efficiency and quality throughout the healthcare ecosystem.  

Dustin was speaking at the recent Summit for Clinical Ops Executives (SCOPE) with Rakesh Maniar, head of eClinical technologies at Merck. They serve as co-leads for the TransCelerate eSource workstream and work collaboratively with sister workstreams for clinical content and reuse and digital data flow, notes Dustin. 

The eSource group has categorized electronic data sources into four buckets, including those for the collection and transfer of data from internal sponsor sources or external vendors into data repositories/warehouses that do not flow into a case report form (CRF); the collection and management of clinical data from non-site personal, wearables, and sensors; direct entry of clinical data by site staff into a mobile application or electronic data capture (EDC) system; and the collection and reuse of data for use in clinical research from EHR systems.   

TransCelerate’s eSource workstream started in 2015 and the first orders of business included uncovering common aspirations to modernize data collection and technology vendor willingness to engage with pharma, says Maniar. This prompted CDISC mapping to FHIR and EDC and the identification of vendors to participate in HL7 FHIR connect-a-thon work.   

CDISC—the Clinical Data Interchange Standards Consortium—is a standards development organization dealing with medical research data linked with healthcare. FHIR—Fast Healthcare Interoperability Resources—is a standard describing data formats and elements and an application programming interface for exchanging EHRs. The FHIR standard was created by the Health Level Seven (HL7) international healthcare standards organization.  

In 2018, the mapping initiative was launched by TransCelerate and member companies began an EHR-to-EDC pilot project with Duke. Understanding of site training needs and eSource capabilities was also identified, says Maniar. Global regulatory agencies were engaged in 2019, revealing areas of differences and alignment in their thinking that TransCelerate hopes to see harmonized. 

Tools And Resources 

Among the eSource assets and industry resources offered by TransCelerate are, most recently, the eSource site maturity curve and CDISC lab semantics in the FHIR implementation guide, says Maniar. This year, the eSource workstream has also been more heavily engaging site advocacy groups and collaborating with standards-setting organizations such as HL7. It also did an initial regulatory analysis across different geographies to enable and foster eSource adoption. The team looked at 17 areas commonly used in the clinical trials process across 16 guidances and papers published by regulators—including the U.S. Food and Drug Administration, European Medicines Agency, the U.K.’s Medicines and Healthcare products Regulatory Agency, and Japan’s Pharmaceuticals and Medical Devices Agency—to identify consensus, differences, and gaps, Maniar says.  

Gaps were identified in terms of archiving, data standards, fraud detection, interoperability, monitoring expectation, and ownership. The analysis was done before the pandemic, he notes, and therefore does not reflect temporary waivers around privacy laws related to data monitoring and verification that have since been issued by agencies around the globe.  

TransCelerate has published a site qualification questionnaire as a tool for sites to assess where they are on the “eSource maturity continuum.” Sites whose maturity falls between “ad hoc” and “innovative” will be somewhat eSource-enabled but do not yet have an EHR, Dustin offers as an example.  

Current Projects 

Objectives for the eSource workstream group in 2021 include a lab implementation guide pilot project with the Society for Clinical Data Management (SCDM) focused on data exchange between sites and sponsors and teaching internally maintained pharma systems to “speak HL7 natively,” says Dustin. The idea is to find sites that have a FIHR server set up with their EHR to avoid the need for a lot of custom integration work and identify TransCelerate member companies ready to partner with SCDM to directly pull FHIR HL7 data from those sites and ingest it into their clinical data systems and convert it to CDISC SCDM submission formats for analysis and routing to regulatory agencies.  

The pilot project will likely involve a mix of test data and live clinical trials, Dustin says. Getting data directly from sites, if even possible, can take up to a month through the current process involving data transcription, monitoring, source data verification, and ultimate data transfer, he notes. “This would change that to days.” 

One priority this year is the multi-stakeholder Vulcan accelerator project—involving pharma companies, technology companies, academic institutions, and regulatory authorities—collectively endeavoring to accelerate eSource and ensure healthcare enterprise standards meet the needs of clinical trials, says Dustin. “Real-world data is doing that EHR-to-EDC connection by pulling in and using EHR data to identify a clear need to develop FHIR HL7 capabilities.” 

The Vulcan project also seeks to “build the last mile for other companies and data sources that are already plugged into EHRs to then map them to clinical trials,” Dustin continues. “That would eventually feed back into HL7 natively to understand… what could be added to the standard [to]… reduce the amount of mapping we have to do.” 

In addition, the Vulcan accelerator project aims to make the schedule of activities in protocol documents “more real for the EHR,” says Dustin. Among the goals here is the ability to translate a visit into an encounter and a next-visit date into a visit date field in the EDC, as well as enable sites to use their own apps and systems to send out notifications, engage patients, and otherwise “further the patient journey into clinical trials.”