Food and Drug Administration

Guardian Research Network, Inc. (GRN) is a non-profit, tax-exempt corporation organized and operated under Section 501(c)(3) of the Internal Revenue Code based in Spartanburg, SC. Enhancing clinical trial quality and improving patient outcomes involves interactions among healthcare providers, researchers and service providers sharing a common interest in expanding both the quality of clinical care coordination as well as the quantity of treatment alternatives. Ongoing challenges and inefficiencies in clinical trial enrollment stem largely from the realization that a large percentage of eligible patients are geographically and/or socioeconomically unable to receive treatment where the best clinical trials are being offered. For such marginalized patient populations, enrolling in a clinical trial often requires the patient to expend significant time, cost, and energy in traveling to the study site.

We greatly appreciate the opportunity to provide our comments in response to the draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision Making for Drug and Biological Products issued September 30th, 2021. This draft guidance provides sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.

As the Agency continues to develop this guidance, GRN respectfully requests the FDA consider the commentary raised in this submission. Future revisions to this guidance document should stress the dynamic nature of this topic and highlight FDA’s flexibility and receptivity in engaging with data providers to creatively explore other concerns, approaches, and considerations specific to drug development programs.

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