Pfizer has partnered with non-profit healthcare system Ochsner Health System to develop digital models that aim to improve clinical trials. The multi-year strategic alliance involves Ochsner’s innovation lab innovationOchsner (iO) and Ochsner Research.
Pfizer and Ochsner intend to boost clinical trial experience and facilitate easy participation in clinical research for patients as well as healthcare professionals.
The partners will create faster and better access and connectivity to clinical trials, as well as allowing participating patients to explore the new digital tools designed to enhance their experience.
Direct data system integration and automated study conduct tools are expected to reduce participating clinicians’ manual data entry burden.
Pfizer added that research groups will see efficiencies via interoperability that could lower costs while increasing capacity. The project’s first stage was a proof of value phase where researchers were able to transfer mock patient data from Ochsner’s electronic health record (HER) system to Pfizer’s electronic data capture system, which is used in its clinical trials.
This phase was meant to provide insights into the gaps and variances between data collected in EHRs and patient-reported data from trials. The integration of EHR data into clinical trial databases would mitigate manual data entry burden, save time, reduce cost and speed up the studies.
Ochsner adopted the Fast Healthcare Interoperability Resources (FHIR) standards for secure and open healthcare data exchange.
As part of the collaboration, Pfizer and the healthcare system will create a model to apply FHIR to consistently, reliably and securely collect trial data within hospital and clinic electronic systems.
Pfizer Global Product Development Operations Center of Excellence vice-president Rob Goodwin said: “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.
“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 of the project will work on devising new approaches to digitise clinical trials, with focus on patient preferences for access to and use of their health data.