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Research

Data Curation in the Modern Medical Era

Author: Theodore Leng, MD, MS, Verana Health
October 2021
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Leading with integrity, Verana Health is the trusted data and technology partner of the American Academy of Ophthalmology’s IRIS® (Intelligence in Research and Sight) Registry, a database of real-world patient data comprised of 400 million patient visits from 70 million unique patients—all of which are reported by nearly 14,000 ophthalmologists.

To appreciate how Verana Health can propel medicine into the age of big data, let’s examine how curation of the IRIS Registry has enabled growth in ophthalmology.

The IRIS Registry

The Academy founded the IRIS Registry as a benefit for Academy members who wished to participate to satisfy quality reporting requirements, linked to reimbursement through the merit-based incentives payment system, or MIPS. Clinicians allow integration of the IRIS Registry technology with their electronic health records system to facilitate data upload, and each member reviews and initiates the submission of their data to the MIPS program via this platform.

The IRIS Registry is one of the earliest examples of a medical specialty society building a robust record of patient information—and in doing so, created the largest real-world database of its kind. Still, additional data curation was needed to improve the utility and applications of the IRIS Registry data. That’s where a partnership with Verana Health comes in. 

VeraQ™ Powering Data Curation

Curation is the process of collating, verifying, and organizing data points to improve the accuracy and usability of information housed in a database for multiple applications. At Verana Health, curation is powered by VeraQ™, a clinician-directed population health data engine enhanced by proprietary artificial intelligence (AI) to produce disease-specific, fit-for-purpose data modules, Qdata™. 

To produce Qdata that preserve the integrity of the original clinical context from a healthcare provider’s point-of-care notes and inputs, natural language processing (NLP) and machine learning (ML) are coupled with the human touch of subject matter expertise. In-house ophthalmologists collaborate with quantitative science and data quality experts to ensure that raw source EHR data entered into the IRIS Registry are organized and categorized according to international data standards. Then, data are linked among EHRs as well as with other sources, such as medical claims, pharmacy claims, and mortality data. This human plus technology process assures that data are not only compliant with MIPS reporting requirements, but can also be used to address the scientific objectives of the Academy and its members. Moreover, these data can also be used to generate new questions and hypotheses that may inform the development of medical products designed to improve the care and outcomes of patients with ophthalmic diseases and disorders.

Elevating the Drug and Device Development Lifecycle

Examining each step of the lifecycle of regulated medical products—clinical development, launch strategy, commercial insights, post-approval evidence, and market expansion—illustrates how Qdata—Verana Health’s clinically true, curated datasets from point-of-care data sources such as the IRIS Registry—can facilitate research and improve medical product development and utilization. 

  • Clinical development: During the early phases of a drug’s development, identifying clinics with requisite volume and patient types could be key to executing efficient trials. Curated Qdata can be used to pinpoint clinical trial sites that can make significant contributions to trial enrollment objectives.
  • Launch strategy: When industry leaders with limited resources are weighing a product’s launch strategy, they may wish to target particular geographic regions with dense populations of patients that fit a product’s label. Or, if a recently approved drug could supplant an older drug to become the dominant treatment for a certain condition, industry members may wish to target areas with high use of the older drug that they would be competing with. 
  • Commercial insights: The IRIS Registry houses real-world data points such as visual outcomes, dosing regimens, and adverse event rates. As industry leaders seek to understand how their drug is being used in the real world—and how usage patterns are linked with outcomes—they can leverage Verana Health’s analysis of Qdata to inform quality insights. 
  • Post-approval evidence: Safety data from tightly controlled clinical trials are useful for regulatory approval. However, after a drug is introduced to the real world, safety assessments are key to ensuring that patient safety is maintained. Researchers can efficiently uncover safety signals in real-world patient populations in the highly curated  VeraQ data engine that can serve as both a retrospective and prospective data source.
  • Market expansion: Companies seeking to modify, preserve, or expand a drug’s label may find the curated Qdata housed in the real-world VeraQ data engine useful during their interactions with regulatory bodies. 

The Next Age of Data-driven Medicine

By reducing lag time between data entry and data curation in VeraQ, Verana Health has been instrumental in ensuring that the Academy’s IRIS Registry closely reflects conditions in the real world. Industry partners at any stage in the lifecycle of a product—from those looking for a successful launch to those seeking opportunities for market expansion—may wish to leverage curated IRIS Registry Qdata via VeraQ to guide them toward efficient product growth, the foundation of which is an understanding of real-world patient dynamics.