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Advancing the Use of Real-World Data for Regulatory Decision-Making

Author: Dr. Matthew Roe and Rebecca Hancock
December 2021
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Verana Health recently shared comments with the Food and Drug Administration sharing our support for its draft guidance document, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry.” 

Because Verana Health is committed to helping clinical researchers unlock quality insights with real-world evidence, we support FDA’s focus on providing guidance for the use of electronic health records (EHRs) and medical claims data in clinical studies to inform regulatory decision-making. 

As a trusted partner to leading medical specialty societies, Verana Health is accelerating research with insights from the world’s largest clinical real-world data (RWD) datasets in medicine, including the American Academy of Neurology’s Axon Registry, the American Academy of Ophthalmology’s IRIS Registry, and the American Urological Association’s AQUA Registry.

By applying advanced analytics to disease-specific curated datasets, Verana Health leverages these registries to enhance evidence generation, accelerate clinical research and enable quality reporting for contributing practices. We see tremendous potential for advancing scientific understanding and improving patient care. 

Our comments to FDA include our perspective and insights on key topics related to the use of real-world data for regulatory purposes, including Data Linkage and Synthesis, Addressing Missing Data, and Data Quality Considerations During Data Accrual, Curation, and Transformation. These are issues Verana has made substantial progress on in our work with the real-world registry data sets that we manage, and we provided input to FDA reflecting our experience.


Verana Health applauds FDA’s efforts to advance the use of real-world data for regulatory decision-making. We appreciated the opportunity to provide comments and we look forward to working with FDA as a trusted data and technology partner to advance the understanding, reliability, and relevance of different types of real-world data to support medical product development, transform clinical trials, and ultimately improve patient care.

Read our full comment letter here.