TriNetX to provide FDA with 'rapid access' to RWD network

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/dusanpetkovic)
(Image: Getty/dusanpetkovic)

Related tags: Real world data, RWD, TriNetX

TriNetX is a new technology partner working on the FDA’s Sentinel System, led by HPHCI, which has signed a contract worth up to $220m to develop a new Sentinel Innovation Center.

The Cambridge, MA-based company has partnered with health care organizations aross 23 countries and thousands of sites, and recently was named as a technology partner in two coordinating centers of the US Food and Drug Administration’s (FDA) Sentinel System.

Initiated in 2009 and led by the Harvard Pilgrim Health Care Institute (HPHCI), the program uses electronic health care data to monitor the safety of FDA-regulated drugs. Moving forward with the program, HPHCI was recently awarded a five-year contract by the FDA worth up to $220m to develop a new Sentinel Innovation Center.

Sebastian Schneeweiss, MD, ScD of Brigham and Women's Division of Pharmacoepidemiology and Pharmacoeconomics will head up the center, which will be co-led by investigators from the Duke Clinical Research Institute, Kaiser Permanente Washington Health Research Institute in collaboration with the University of Washington School of Public Health and the Vanderbilt University Medical Center Department of Biomedical Informatics.

More than 60 health care, academic, and technology organizations – including TriNetX – will partner with the institute as part of the continued work.

“As a new technology partner for Sentinel, FDA will have the ability to use TriNetX to rapidly query our vast real-time EMR data network which is made up of the leading health care organizations across the US,”​ Michael Sullivan, director of the US public sector at TriNetX​, told us.

This will include, for example, examining specific patient population characteristics, such a diagnosis, procedures, medications, and lab values, from the company’s global health research network of more than 300m patients.

According to Sullivan, TriNetX’s solution will complement the data and analytic tools currently used to support the Sentinel System.

“TriNetX will partner with the Sentinel’s Operations Center and will participate in the newly established Innovation Center which is involved with bioinformatics, advanced analytics, novel data sources, and randomized trial and RWE innovation,”​ he added.

“Working in close coordination with HPHCI, we are looking forward to providing FDA with rapid access to our robust real-world data network enabling FDA to generate a real-time understanding of new drug approvals and treatment patterns, which we believe has the potential to be a game-changer for the Agency.”

Related topics: Clinical Development

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