- Ochsner Health System, Louisiana’s largest non-profit academic healthcare system, is partnering with drug maker Pfizer to develop a way to improve healthcare interoperability between EHRs and clinical trial data using the Fast Healthcare Interoperability Resources (FHIR) standard.
This interoperability will reduce the burden of manual data entry, save time, decrease cost and accelerate the speed of clinical trials, Ochsner and Pfizer explained in a release.
The partnership is in the form of a multi-year strategic alliance to develop innovative models for clinical trials and ease participation in clinical research for patients, clinicians, and researchers.
Ochsner Chief Clinical Transformation Officer Richard Milani explained that there are extra steps involved in clinical trials that can be eliminated, creating efficiencies and reducing costs of clinical trials.
“The alliance is taking advantage of tools that are available today to create a more efficient method of taking patients through a clinical trial. In this way, we can expose more patients to clinical research and be able to obtain the data and get it to the right groups in the most efficient manner possible,” related Milani, who is also medical director of innovationOchsner.
Milani told HITInfrastructure.com that the alliance with Pfizer is not only working on interoperability between the EHR and the clinical trial data, but also on improving data collection from patients.
“We can collect a lot of the information from the patient at home, such as biologics data and survey responses,” he said.
Ochsner uses Epic as the supplier of its EHR. The data collected from the patient at home is transmitted securely into the EHR, Milani explained.
The alliance’s first project was a “proof of value” test in which researchers were able to transfer mock data from Ochsner’s EHR system to Pfizer’s electronic data capture system using the FHIR standard. The test was designed to identify gaps and variances between data collected in EHRs and data from clinical trials.
The FHIR standard, developed by the nonprofit organization Health Level Seven International (HL7), is an international common data standard to promote interoperability and accelerate health data sharing.
“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,” said Rob Goodwin, Pfizer's Vice President, Operations Center of Excellence, Global Product Development.
“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,” he added.
The Ochsner-Pfizer alliance aims to create faster, improved access and connectivity to clinical trials for patients, with the goal of better experiences and outcomes.
Milani identified several benefits from the alliance. It will lower clinical trial costs, improve the efficiency and speed of the clinical trial process, increase the number of people who would be willing to participate in clinical trials, and lessen the data entry burden on clinical trial personnel. He noted that these benefits can be realized by any organization that conducts clinical trials, such as the National Institutes of Health, universities, and medical industry associations.
For the next phase of the alliance, the two organizations will work on new ways to digitize the patient and clinician experience in clinical trials. This work will focus on patient preferences regarding access to and use of their health data with the goal of enhancing the quality and value of clinical research interactions for all participants.
“We are taking advantage of the tools and systems that exist today and applying them to clinical research. The fundamentals have been accomplished and the next phase will be to utilize these systems in an actual clinical trial,” Milani concluded.