CONTEXT: “Ground-breaking” can be an overused word, like “Leading company” or “Bitcoin”, but this research gets close to being worthy of the title. This author may be a little too excited at seeing a retrospective study generate the same outcomes as Phase 3 RCT studies, but the implications are big. Don’t expect registries to take the place of pivotal RCTs, but do expect to see more use of existing data sets to help drive innovation in healthcare.
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1. “In this electronic health record (EHR) based registry study, investigators replicated the study design and evaluated the outcomes using RWD contained in the American Academy of Ophthalmology IRIS→ Registry (Intelligent Research in Sight), the world’s largest single-specialty clinical database.”
2. “SAN FRANCISCO–(BUSINESS WIRE)–Verana Health, a healthcare technology and analytics innovator transforming multi-specialty clinical data into real-world evidence, today unveiled ground-breaking research during the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.”
3. “In a first-of-its kind study, Verana Health demonstrated that it was able to successfully use real world data (RWD) to replicate primary outcome measures of two large-scale randomized controlled trials (RCTs) in ophthalmology—the VIEW 1 and VIEW 2 (VIEW 1/2) pivotal trials.”
4. ““Before now, we did not know whether phase 3 clinical trial data and outcomes were represented in the real-world data contained in the IRIS Registry,” said Theodore Leng, MD, Medical Advisor to Verana Health and Director of Clinical and Translational Research at the Byers Eye Institute at Stanford, Stanford University Medical School.”
5. ““We’re excited to discover that in this retrospective study, primary outcome measures were reproducible in the IRIS Registry, thus making it the very first time that a large-scale, phase 3 randomized controlled trial in ophthalmology was able to be replicated using a real-world data set.”