Note: Some of this material will be published in Applied Clinical Trials, June 2016.
We, in the biopharmaceutical clinical research world, are creatures of habit, doing our jobs in a consistent, repeatable process, usually driven by SOPs and systems. Change comes slowly; old habits die hard.
When EDC systems came of age around the turn of the century, health records were an inaccessible mess – and healthcare clinical data was hardly of sufficient quality to support what we felt was our gold standard of randomized clinical trials. So we continued to treat clinical research data as an entirely separate process, with data entered into CRFs manually. Electronic health data was scarce and dirty, didn’t line up with research databases, used different terminologies, and simply was too difficult to reuse.
But, now that the era of digital health is upon us in the USA and other countries, it’s time for a fresh look at how we collect research data. What if we could make a great leap forward by completely changing our approach through EHR eSource? Would we dare to try?
“Source” is the initial recording of data for a clinical study. When the original recording is on digital media rather than paper, it’s “eSource”. Clinical trials have used eSource for years in ECG readings, lab results and other measurements. The FDA eSource Guidance describes different ways to transmit eSource data (from direct capture, devices, transcription, EHRs or PRO instruments) to an eCRF (or EDC) system, and several approaches have been proposed for trying to feed EHR data into our existing EDC-based processes. Last year the FDA even asked for demonstration projects to explore such approaches.
But a more recent draft Guidance on Use of EHR Data in Clinical Investigations offers another take entirely with explicit goals to “facilitate the use of EHR data in clinical investigations” and to “promote the interoperability of EHRs” with clinical research systems. The guidance recognizes that the ONC Health IT Certification Program can indicate the readiness of EHRs to support research. And ONC’s Advancing Care Information initiative (the successor to Meaningful Use) relies heavily (among other things) on leveraging APIs to make health data more timely and accessible to patients and caregivers.
This is where HL7’s FHIR® platform standard comes in:
- FHIR’s Data Access Framework will provide a universal API to EHR systems that can be used to populate much of a casebook in a clinical database.
- The Smart on FHIR specification demonstrates how patients can grant researchers access to their data through electronic informed consent, as well as input outcome data through smartphones and browsers – data that can be directed to an EHR or a trusted third-party cloud-based research repository simply by selecting the appropriate target FHIR server.
- Since EHR data is eSource, FHIR can also provide authorized access to remote study monitors.
- And since FHIR can update as well as read data, it can also support the processing of data clarification transactions, thus making it possible to synchronize EHR records with clinical databases, improving transparency and traceability for both monitors and regulatory inspectors.
- What’s more, FHIR makes it possible for regulatory reviewers to delve into the full EHR database to explore, for example, serious adverse events, in more depth than was ever possible before.
But is it really necessary to have an eCRF system in the middle at all? In other words, can we use EHR data directly to feed our analysis so that all health data could potentially be reused as research data? What could be more transparent, traceable, and efficient than going from source to analysis with as few steps and transformations as necessary? But that’s a provocative question for another day.