Supporting Launched Products with Real-World Evidence
The Importance of Real-world Data
Across the healthcare industry, real-world evidence (RWE) is vital throughout product life cycles. While randomized controlled trials (RCTs) are still required, RWE fills in critical gaps in drug development, commercial decisions, and post-launch pharmacovigilance.
“Real-world evidence generation is not a replacement for clinical trials during drug development,” said Hélène Karcher, Novartis Global Head of Real-world Evidence for Ophthalmology, Respiratory and Allergy. “But real-world evidence generation is critically important to optimize clinical development, access and adoption of new pharmaceutical products.”
Results gained from RCTs do not always reflect real-world practices. Patient enrollment is often limited to a narrow population, and protocol parameters include strict treatment schedules and monitoring. While RCTs provide some insight, they lack flexibility and adaptations seen in the real world. Thus, the need for RWE becomes apparent, especially for life sciences organizations, looking to better understand the characterization of patient demographics, clinical outcomes, treatment patterns, and safety profiles of their products in the real world.
Analysis of Large-scale RWE at Verana Health
At Verana Health, exclusive partnerships with medical societies have been established to leverage high volume real-world data (RWD) with sophisticated data curation. Having exclusive access to vast amounts of electronic health record (EHR) data, Verana Health is able to help address a challenging issue with RWD: gaining insight from structured EHR data such as demographic details, visit history, and routine tests or measurements as well as EHR data, which is difficult to decipher and exists within unstructured clinical notes. Verana Health utilizes artificial intelligence (AI) techniques, such as machine learning (ML) and natural language processing (NLP), to curate and analyze RWD at scale.
Verana Health’s Collaboration with Novartis
Verana Health is the end-to-end data and technology partner for the American Academy of Ophthalmology IRISⓇ Registry (Intelligent Research in Sight), the largest specialty clinical data registry in all of medicine. Companies, researchers, and clinicians collaborate with Verana Health to analyze this vast IRIS Registry database to help support life sciences’ research needs across the drug or device lifecycle.
One notable collaboration is with Novartis, which is one of the largest pharmaceutical companies in the world and the developer of BEOVUřⓇ (brolucizumab-dbll) , a physician-administered intravitreal injection for patients with neovascular age-related macular degeneration (nAMD). Understanding that generating a large enough sample size for a new product would be challenging through traditional means, Novartis turned to Verana Health to generate RWE for BEOVU in an effort to better understand the clinical characteristics of their initial patients to postmarketing safety surveillance using IRIS Registry data.
“We chose to partner with Verana Health for a number of reasons,” said Karcher. “First, because the product was only on the market for a few short months, generating a large enough sample size was challenging. We were able to address this by working with Verana Health, which is entrusted with data from the largest clinical database for ophthalmology in the U.S. Second, Verana Health excels at quickly creating quality datasets and refreshing them frequently, which benefits launch cases and the ability to monitor for safety signals.”
This collaboration yielded valuable RWE insights for Novartis on how patients responded to BEOVU. These insights revealed a heavily pre-treated patient population using BEOVU (a population that differs significantly from clinical trials), up-to-date treatment patterns, and critical risk/benefit analyses obtained from curated IRIS Registry Data.
Beyond the generation of real-world insights to understand a drug’s effectiveness and safety profile, Verana Health’s expertise in RWD curation and analyses better allows for unlocking the value of unstructured EHR data for drug development cycles and patient care through AI/NLP, standardization and quantification of EHR data from multiple sources, and high quality postmarketing studies using an FDA-accepted data source.
“Verana Health has been responsible, adaptable and nimble,” said Karcher. “Our projects have benefited from Verana Health’s excellent clinical, analytical and data expertise. Verana Health is a great data partner and data source for life sciences company pre and post-approval teams.”
To learn more about Verana Health’s projects with Novartis on BEOVU, click here to download the white paper.
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