The innovation lab at Louisiana-based Ochsner Health System is partnering with Pfizer Inc. to develop new models for clinical trials, including applying FHIR standards so that clinical trial data can be collected reliably and securely within hospital and clinic electronic health records.
Louisiana’s largest nonprofit academic healthcare system, Ochsner said it has formed a multi-year strategic alliance with Pfizer to integrate EHR data into clinical trial databases, which has long been a goal of research institutions, industry and regulators.
The Ochsner-Pfizer alliance aims to create faster, improved access and connectivity to clinical trials for patients. Participating patients will have the opportunity to test out new digital tools designed to make the clinical trial experience more inclusive and enjoyable. It also said clinicians will benefit from reduced manual data entry as a result of direct data system integration and automated study conduct tools, while research groups will experience efficiencies from interoperability that may lower costs while increasing capacity.
In a 2016 Healthcare Informatics interview, Wayne Kubick, chief technology officer of standards organization HL7, described some of the potential to improve data sharing between clinical practice and clinical trials. “The clinical research business in the pharmaceutical industry is pretty backwards technologically. It takes organizations a long time to change. There is strong regulatory fear and there is a lot of effort involved in even making a small technological upgrade in a big pharmaceutical company,” he said. “A new version of a system can take a year to implement.” He said FHIR makes it possible to tap directly into EHR systems and reach out directly to patients, as well as to provide a capability for putting data back into EHRs. “You have the possibility of tapping into data, not just for randomized clinical trials, but also for an analytical view of what is really going on in terms of patient populations for these targets being explored for various drug products.”
Kubick said one early potential use case involves being able to look at what types of patients are in an EHR to see who would be eligible for a clinical trial and whether they would be interested in participating directly. Another is being able to pull in EHR data to pre-populate a case report form.
The strategic alliance’s first project began with a “proof-of-value” phase in which researchers successfully transferred mock data from Ochsner’s EHR system to Pfizer’s electronic data capture system used in Pfizer clinical trials. The experiment aimed at understanding the gaps and variances between data collected in electronic health records and patient-reported data from clinical trials.
The Ochsner-Pfizer alliance project aims to build a model for applying FHIR standards so that high-quality clinical trial data can be collected consistently, reliably and securely within hospital and clinic electronic systems.
“We’re pleased that we succeeded in transferring core data types collected in healthcare provider electronic health records to Pfizer’s clinical trial data capture system using FHIR standards. To the best of our knowledge, this is a first for our industry,” explained Rob Goodwin, vice president, operations center of excellence, global product development at Pfizer, in a statement. “There is more work ahead, but this is a significant step forward in simplifying data capture for clinical trials, and the first of many pioneering solutions we hope to develop through our partnership with Ochsner.”
