COVID-19 Clinical Real-World Data Being Utilized to Monitor for Potential Drug Shortages
Cambridge, MA, May 21, 2020 — TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE) is working with the FDA Sentinel Operations Center at the Harvard Pilgrim Health Care Institute (HPHCI) to monitor priority drugs used for the care of hospitalized COVID-19 patients.
HPHCI is leveraging TriNetX’s de-identified COVID-19 clinical data set to support studies aimed to sequentially monitor sedatives and priority drugs used to assist with mechanical ventilation, therapies for respiratory disease, and other medications used to treat COVID-19. The purpose of these projects, which includes examining both inpatient and outpatient drug usage, is to assess changing patterns of use to support regional assessments of drug use and to evaluate the possibilities of medicine shortages.
Representatives from the FDA, HPHCI and TriNetX presented preliminary findings and discussed how to best use real-world data to support COVID-19 evidence generation during the Reagan-Udall Foundation for the FDA COVID-19 Evidence Accelerator Lab Meeting on May 14.
“Rapid and interactive access to a large, growing, and frequently updated data source of COVID-19 patients is critical for monitoring drug use in these patients,” said Jeffrey Brown, PhD, from the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. “TriNetX is providing the right data at the right time in a way that makes it easily available to decision makers.”
“We are pleased to be able to work with Harvard Pilgrim through the Sentinel program to help inform decision makers when analyzing utilization and safety of drugs,” said Gadi Lachman, Chief Executive Officer at TriNetX. “We are especially happy to be able to provide near real-time, real-world data during this time of COVID-19 when the FDA is being called on to make critical decisions every day.”
TriNetX is a technology partner for the Sentinel System, an active surveillance system sponsored by the FDA to monitor the safety of regulated medical products using pre-existing electronic healthcare data from multiple sources. The Sentinel System is operated by HPHCI as part of the FDA’s Sentinel Initiative, a long-term effort to improve the FDA’s ability to identify and assess medical product safety issues.
TriNetX is the global health research network that connects the world of drug discovery and development from pharmaceutical company to study site, and investigator to patient by sharing real-world data to make clinical and observational research easier and more efficient. TriNetX combines real time access to longitudinal clinical data with state-of-the-art analytics to optimize protocol design and feasibility, site selection, patient recruitment, and enable discoveries through the generation of real-world evidence. The TriNetX platform is HIPAA and GDPR compliant. For more information, visit TriNetX at www.trinetx.com or follow @TriNetX on Twitter.
About Harvard Pilgrim Health Care Institute’s Department of Population Medicine
The Harvard Pilgrim Health Care Institute’s Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School. Created in 1992, it is the first appointing medical school department in the United States based in a health plan. The Institute focuses on improving health care delivery and population health through innovative research and teaching.
Harvard Pilgrim Health Care Institute