CAMBRIDGE, Mass., Dec. 18, 2018 /PRNewswire/ -- TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the creation of real-world evidence (RWE), today announced the results of a study confirming that the TriNetX platform successfully leverages real-world data (RWD) to generate RWE to replicate results from randomized clinical trials (RCTs). The study, published in the World Journal of Diabetes, mirrored the RCT results validating the cardiovascular advantages of sodium-glucose co-transporter-2 (SGLT2) inhibitors when treating patients with diabetes and showed the applicability of SGLT2 to the U.S. population.
The study used TriNetX, a global federated research network providing statistics on electronic medical records (EMR), to analyze approximately 38 million patients in 35 healthcare organizations in the United States. The study compared the records of 46,909 patients who had taken SGLT2 inhibitors with 189,120 patients who had taken dipeptidyl peptidase-4 (DPP4) inhibitors. In five different strata, the risks of experiencing a cardiovascular event were significantly less for those using SGLT2 than for those in the control group with risk ratios ranging from 0.62 to 0.81.
"The results showed that this type of analysis using real-world data could replicate the results coming from much more complex and costly studies," said Manfred Paul Stapff, MD, PhD, Chief Medical Officer of TriNetX who led the study. "The study validates our methods and the quality of data in our network. It also shows that TriNetX is perfectly positioned to take advantage of the FDA's recently announced framework evaluating ways to incorporate greater use of real-world evidence in drug development."
As a result of the 21st Century Cures Act, signed into law on December 13, 2016, the Food and Drug Administration (FDA) has been advancing efforts to use RWE to improve regulatory decisions. The FDA has already taken the initiative to pilot projects to further the understanding of potential uses of RWD and RWE.
TriNetX is the global health research network founded on the idea that incorporating RWD results in better clinical trial design, improves the site selection process to expedite time to market of new therapies, and creates RWE to advance the collective understanding of human health.
"There is tremendous potential to advance scientific discoveries when new, more efficient methods are introduced to researchers who seek to understand and gauge efficacy, cost burden, adverse events, as well as unintended positive outcomes of therapies," said Gadi Lachman, TriNetX CEO. "This cardiovascular study is just one of many examples of how the TriNetX platform is helping the research community generate real-world evidence faster and more easily than ever possible before."
The complete cardiovascular study can be reviewed in the World Journal of Diabetes located at:
TriNetX is the global health research network that revolutionizes clinical research and enables discoveries through the creation of real-world evidence. TriNetX combines real time access to longitudinal clinical data with state-of-the-art analytics to answer complex research questions at the speed of thought. For more information, visit TriNetX at http://www.trinetx.com or follow @TriNetX on Twitter.