Implementation of a commercial federated network of electronic health record data to enable sponsor-initiated clinical trials at an academic medical center

Abstract

Background: A commercial federated network called TriNetX has connected electronic health record (EHR) data from academic medical centers (AMCs) with biopharmaceutical sponsors in a privacy-preserving manner to promote sponsor-initiated clinical trials. Little is known about how AMCs have implemented TriNetX to support clinical trials.

Findings: At our AMC over a six-year period, TriNetX integrated into existing institutional workflows enabled 402 requests for sponsor-initiated clinical trials, 14 % (n = 56) of which local investigators expressed interest in conducting. Although clinical trials administrators indicated TriNetX yielded unique study opportunities, measurement of impact of institutional participation in the network was challenging due to lack of a common trial identifier shared across TriNetX, sponsor, and our institution.

Conclusion: To the best of our knowledge, this study is among the first to describe integration of a federated network of EHR data into institutional workflows for sponsor-initiated clinical trials. This case report may inform efforts at other institutions.

Keywords: Clinical trials; Data warehouse; Electronic health record; Secondary use.