In what could be the first time that real-world data are used in an academic setting, Clinerion is offering up its blinded electronic health records to help train clinical research master’s students at Dresden International University (DIU).
The collaboration with DIU’s Master’s Program in Clinical Research will begin next month with the 2019-2020 cohort, Basel-based Clinerion said Monday.
The company will offer a collection of the de-identified electronic health records of patients in its hospital network. And the students will use the data to generate real-world evidence for their master’s thesis.
Clinerion’s platform, called Patient Network Explorer, houses patients’ records related to demographics, prescribed medication, laboratory results, diagnosis and treatments, according to the company. Currently, the system is used to help Clinerion’s clients to improve study design, select trial sites and identify and enroll patients faster.
“Clinerion data is secure, transparent, scalable and international and therefore a perfect fit for our program and for our students’ needs,” course director, Ben Illigens, said in a statement.
The students, who will have already been trained in basic clinical trial concepts, will learn how to identify study cohorts, how to test feasibility and improve study protocols with real-time feedback. Using Clinerion’s real-world data, they will analyze their respective patient data, and results will be presented at international meetings and published in peer-reviewed scientific journals.
“This partnership with the Dresden International University will also generate clinically valuable real-world evidence, which will further academic research at the students’ home universities around the world,” Clinerion CEO Ian Rentsch said.
The partnership comes as the FDA—under the mandate of the 21st Century Cures Act—is exploring the use of RWE to support its decision-making.
Last July, the FDA published guidance on the use of electronic health record during clinical investigations—the very practice Clinerion has been offering. Last December, the FDA unveiled a framework that’s designed to guide the agency’s use of RWE in its drug development oversight. Then in May, it issued draft guidance for the industry on the types of real-world information the FDA will consider for regulatory submissions.