CAMBRIDGE, Mass., July 29, 2020 /PRNewswire/ — TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), today announced it will be conducting an in-depth retrospective medical record review on a sample of U.S. hospitalized COVID-19 patients to create a clinically-enriched, regulatory-grade dataset to support drug treatment and vaccine research. The review will include 200 patient charts from four healthcare organizations (HCOs) who are part of the TriNetX network. The randomly selected medical records will come from patients who must have been hospitalized with laboratory-confirmed COVID-19 infection and have at least 28 days of follow-up post admission.
“Published research on COVID-19 and its potential treatments is rapidly accumulating,” said Jennifer Stacey, Senior Vice President, Clinical Sciences at TriNetX. “But careful characterization of disease progression, determination of true risk factors, and rigorous evaluation of the effectiveness of potential therapies among patients with severe illness are urgently needed.”
The TriNetX-funded review will use a specified case-finding algorithm and sampling scheme using updated COVID-19 diagnosis and laboratory codes from the WHO and CDC. The review protocol has been approved by a central institutional review board (IRB) as being in compliance with HIPAA regulations, and no protected health information (PHI) will be captured.
Reviewers will extract over 100 key data elements including patient demographics, clinical history, COVID-related care characteristics, and outcomes from both the structured EMR and the unstructured clinical notes, PDF attachments, and scans/images not available in standard EMR or claims databases.
“The depth and breadth of the review and the dataset it creates will be of enormous value to researchers looking to set criteria for clinical trials or to track changes in the course of patient care since the pandemic began,” said Pamela Landsman-Blumberg, MPH, DrPH, Vice President, Value & Access Consulting at TriNetX.
Data abstraction is expected to begin in August with the de-identified patient-level research database compiled and available in Q4 of this year.
“University Hospitals Cleveland is beyond thrilled to partner with TriNetX on this first-ever carefully performed and comprehensive chart review focusing on hospitalized COVID-19 patients,” said Grace McComsey, MD, FIDSA, VP of Research and Associate Chief Scientific Officer/Principal Investigator at University Hospitals Cleveland. “The knowledge that will stem from this study will help tremendously in understanding the course of treatment and care techniques since the start of the pandemic and will help in designing better future clinical trials with valuable aims to fight this disease.”
TriNetX’s access to inpatient EMRs, close relationship with HCOs, and advanced analytics capabilities, solves the challenge of getting to deep, unstructured data that is critical to this study. TriNetX’s chart review processes are designed to manage the completeness, conformance, plausibility, lineage, and provenance of the real-world data captured and used for this study.
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.