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Cambridge, MA, May 2, 2019 — TriNetX, the global health research network that optimizes clinical research and enables discoveries through the generation of real-world evidence (RWE), today delivered public comments on the use of RWE at the Reagan-Udall Foundation’s 2019 Annual Public Meeting. Held in Washington, DC, the Reagan-Udall Foundation conducts an annual meeting, open to the public, to share its activities in support of the U.S. Food and Drug Administration.

TriNetX’s comments were delivered in front of the FDA’s new leadership and select Center Directors, by the Company’s Chief Medical Officer, Dr. Manfred P. Stapff.

Read the full transcript below.

Thank you for the opportunity to provide comments. I am Manfred Stapff, Chief Medical Officer of TriNetX.

TriNetX, based in Cambridge, Massachusetts, is a global health research network which enables and supports analyses of real-world data for clinical research, for example to optimize and place clinical trials, and to generate real-world evidence, for example to enable new discoveries, evaluate treatments in actual medical practice, or discover safety signals for pharmacovigilance.

We think that it is critical to include real-world data more pro-actively in public-private partnerships, specifically for novel clinical trial methodologies, improving the efficiency of clinical trial processes, or when addressing urgent public health needs.

As the FDA pointed out in the Framework for Real-World Evidence, the use of real-world data results in better clinical trial design and improves the site selection process, which eventually can shorten the time to market of new therapies. In addition, RWE can be utilized to reproduce or validate the results of randomized clinical trials, which by their nature as manufactured experiments, are somewhat limited in terms of applicability for actual medical practice. In this context I would like to point out that the regulatory definition of “Substantial Evidence” in US code 21 355 (d) contains the words “…the drug will have the effect … under the conditions of use,” which points more to the real world than to the artificial setting of a randomized clinical trial.

The digitalization of the US healthcare and the recent progress in IT technology allows us now to complete randomized clinical trial results with real-world data in the regulatory process. Since much of the real-world data are offered by industry or service providers, this is an area where public-private partnerships can significantly contribute.

Specifically, TriNetX has the capability to:

  • Provide real-world information to protocol authors, to design studies realistically, with feasible and realistic eligibility criteria
  • Test these eligibility criteria through simulation on real-world data
  • Significantly optimize the site ID and pre-screening process
  • Validate the findings of published clinical studies
  • Perform real-world analyses of treatments or cohorts
  • Detect safety signals or put assumed safety signals into real-world perspective

We are eager to make these capabilities available to the FDA and serve as a resource to you as you continue to contemplate how best to leverage real-world data.

In particular, we are eager to see the guidelines that the FDA drafts based on the December Framework. We are supportive of such guidelines.

Thank you again for the opportunity to speak up today, and, as I stated, TriNetX is eager to work with the FDA and the Reagan-Udall Foundation.


About the Reagan-Udall Foundation
The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) not-for-profit organization created by Congress for the purpose of advancing regulatory science – science that is critical to helping the U.S. Food and Drug Administration accomplish its mission.

About TriNetX
TriNetX is the global health research network that revolutionizes clinical research and enables discoveries through the generation 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. The TriNetX platform is HIPAA and GDPR compliant. For more information, visit TriNetX at or follow @TriNetX on Twitter.

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