HL7, CDA, FHIR, CDISC, CDASH. The word jumble surfaces when researchers attempt to integrate clinical data with trial data. It also illustrates a trend where technologists, not clinicians, have control of patents’ information.
We propose there’s another way — an approach that puts the clinician in control of data movement.
First let’s look at the trial data integration problem. Here are data repositories trial teams encounter today:
- Electronic Trial Master Files for storing key regulatory documents
- Electronic Data Capture Systems for recording trial endpoints
- Electronic Health Record Systems (EHR/EMRs) for sourcing some patient trial data
- Electronic Case Report Forms for sourcing other patient trial data
- Central Lab Portals for souring yet other patient data
- IRB databases for compliance correspondence
- Shared drives for internal collaboration
- Paper binders for everything else
Whew. Not only does the sheer number of systems push trials to the bottom of IT’s to-do list, but a patchwork of inter-departmental interests complicates things.
For example, one of the largest cancer research institutions (by trial count) has the need, the team, and the money to integrate their trial management system and EHR. But they can’t get departments to agree on an approach. As a result, the integration gets pushed off again and again.
Integration gets pushed off again, and clinical teams are left to manually move data between clinical systems and trial systems.
So if integration takes forever, and paper transcription is maddening, what’s a site to do? Some sites are experimenting with a system that offers a middle ground, moving documents between systems digitally using their browsers. This approach puts the clinician in control of the data and doesn’t require IT support.
Hows does it work? Trial documents are captured semi-automatically during the course of a trial. They’re then made available to other systems after processing via electronic signatures and source document redacting.
Sound interesting? We’re making it a reality.
Email us at firstname.lastname@example.org. We provide clinical trial data integration for those who do the work to drive cures.