The alliance employs FHIR to quickly transmit data from the EHR with the hope of enhancing access to experimental therapies for patients and clinicians.
Construction of a "digital superhighway" for clinical trials is underway at New Orleans-based Ochsner Health System using HL7's Fast Healthcare Interoperability Resources (FHIR)—possibly the first time this technological solution has been successfully employed to transmit such data from Electronic Health Records (EHR) via FHIR to a study sponsor, in this case, Pfizer Inc.
The first phase of the experiment, transfer of mock data, has been completed, laying the groundwork for faster and more effective data capture and transfer between organizations. Ultimately, this alliance between Ochsner and Pfizer aims to enhance clinician and patient access to experimental therapies.
While FHIR has grown in prominence in recent years, in February the solution leapt to the spotlight when the Proposed Ruling on Interoperability of Electronic Health Information issued by the U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology specified FHIR as the standard by which developers certify their application program interfaces (APIs).
Using the framework as a solution for clinical research data transfer builds on a foundation Ochsner has created through innovationOchsner (iO), an innovation company founded by Ochsner Health System in 2015 to reimagine and revolutionize the delivery and experience of healthcare and health.
"This initiative is trying to create a seamless digital trial experience," says Aimee Quirk, CEO of iO. "For the last several years, we've been using digital tools to connect with patients in the clinical environment and engage them in improving their health. Some of the lessons we've learned are going to aid us in this research initiative we have with Pfizer."
Impact and Implications for Health Systems
The impact and implications of this model could be broad-ranging, and, according to Quirk, could encompass the following outcomes:
- Enhance recruitment to clinical trials via digital submissions through the EHR
- Accelerate speed to more efficiently run clinical trials
- Avoid delays and prevent mistakes in data transfer
- Incorporate vital data generated by apps, wearables, trackers, and home monitoring devices into studies
- Reduce patient travel to participate in clinical trials
- Seamlessly transfer data to the study sponsor, pursuant to patient consent
- Share progress reports and information back to the patients about how they're performing in trials
- Bring new therapies to the community
One key development could be a model or tool to push out information about clinical trials to physicians. It is difficult for clinicians to stay abreast of all potential and experimental therapies for patients and determine if they are eligible for a trial, explains Quirk. Not only would such a tool enhance access for patients, but it also might result in larger pools of eligible patients for those conducting the study.
Integrating EHR data into clinical trial databases has been a long-term goal of research institutions, industry, and regulators. "Such integration would reduce the burden of manual data entry, save time, decrease cost, and accelerate clinical trials," according to a news release issued by Ochsner and Pfizer. "The ongoing challenge has been exchanging data between healthcare systems and clinical trial systems, because each uses different technology platforms and data standards."
While many health apps use FHIR data standards, those involved in the Ochsner-Pfizer initiative say the solution has yet to be adopted for data exchange in industry-sponsored clinical trials.
“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," says Rob Goodwin, vice president of operations at Pfizer's center of excellence for product development in the release. "To the best of our knowledge, this is a first for our industry. 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.”
The next phase on the initiative will include development of new ways to digitize the patient and clinician experience in clinical trials, with attention to patient preferences on access to and use of their health data and with an overarching goal of enhancing the quality and value of clinical research interactions for all participants.
"We're beginning to think about digitizing that patient journey," says Quirk, "and ultimately creating a digital superhighway for clinical trials."
Mandy Roth is the innovations editor at HealthLeaders.