Not too long ago, clinical researchers relied on three-part paper NCR forms to hand-collect patient data distilled from mountain-sized stacks of written medical records. And tear-out pages in the back of a big, clunky Physicians’ Desk Reference, better known as a PDR, were sent via fax machine to FDA for drug safety reporting. Industry professionals underwent a lot of training to ensure that data was source document verified, double-keyed and, after what seemed like an endless stream of queries to correct errors, guaranteed that it was fit for purpose.
Thankfully, that process improved dramatically as health data became digitized with the broad adoption of electronic health records. But given the slow pace of progress in clinical research, especially with state of the art electronic forms still completed by manual data abstraction, the space is overdue for even more technological change, particularly around unlocking the full benefits of healthcare interoperability. And if we get that right, life science companies will have the opportunity to leverage invaluable health data to ensure patient safety, optimize the efficacy of new medications and make the clinical development processes more efficient and less error prone.
We might just connect clinical research to health data sooner than you think. Why? Project Vulcan is on the case. A recent initiative created within HL7’s FHIR Accelerator program, this project group has enlisted more than 30 stakeholder organizations from across healthcare, technology, and life sciences to leverage FHIR the healthcare-specific interoperability standard for clinical and translational research. Since InterSystems joined early last year, I’ve watched the early ideas strategized by Project Vulcan members move closer to functional reality.
But how exactly can healthcare interoperability benefit concomitant medication tracking (two or more drugs given at or during the same time period) or adverse event reporting (capturing ailments that can be related to a medication) along with other areas of clinical research? The answers provide a glimpse into the future.
Interoperability Overhauls Adverse Event Reporting
Every new drug approval starts with safety. If researchers can’t complete Phases 1 and 2 of a clinical trial, they won’t even get the chance to study the efficacy of their medication in a larger population. But proving that a treatment is safe raises tough challenges.
For decades, industry professionals have known that some adverse events fall through the cracks during clinical trials. Let’s say a study subject who’s testing a new heart drug candidate under the care of their cardiologist develops a rash and visits a dermatologist. One month later, when that participant arrives at their next study visit, they might forget to inform the research team of their recent diagnosis – a new rash caused by the study drug being tested.
Right now, far too often, that’s where the story ends. That piece of information — and everything related to it that might say something about the safety of a drug — is gone. The same is true for other real-world data, like additional medications taken by the patient but prescribed by members of their care team not involved with the research. Or simply out of network visits and procedures.
If Project Vulcan succeeds, however, researchers will have a better chance of catching those critical pieces of information through a link between a participant’s electronic health record and the clinical research data record.
FHIR-based interoperability can also streamline adverse event reporting, making the complete snapshot of a patient available delivering important data to key stakeholders. No longer would anyone — patients, researchers or regulators — worry about the emergence of a problem that could have been easily avoided by having a trusted connection to real-world data.
Interoperability also Supports Phenopackets, Schedule of Activities
In addition to EHR data being available to inform clinical trials, one of the goals of Project Vulcan is that data gathered in clinical trials could become more widely accessible — and actionable — thanks to FHIR. The Global Alliance for Genomics and Health (GA4GH) standard for exchanging phenotype data promises to enable the industry to share de-identified case level patient information for use in registries, knowledge base publications and journals.
Anyone who works in clinical trials knows that despite being essential to meeting the research goal, the Schedule of Activities, the step-by-step guide for a particular clinical trial, is prone to oversight and deviation from the plan. The main culprit? Humans. But through Project Vulcan, a FHIR-based representation of the Schedule of Activities could soon enable scheduling automation, reduce the need for manual data entry, and increase study procedure consistency.
We’re Ready to Bring FHIR to Clinical Research
FHIR is already advancing interoperability and removing barriers . We at InterSystems see FHIR’s effects on interoperability every day, whether it’s through the creation of portable apps for clinical decision support or the seamless flow of data between different hospital departments and healthcare organizations. That’s why we built FHIR into our tech stack.
When Project Vulcan hits its goals, InterSystems will be ready to immediately bring fast, seamless data exchange to clinical research. There’s no good reason to delay the arrival of safer, more effective drugs.