PALO ALTO, Calif., Dec. 9, 2020 /PRNewswire/ -- Verantos today announced it has received a grant award from the U.S. Food and Drug Administration (FDA) to implement a multi-year advanced real-world evidence (RWE) study.
The program, "Transforming Real-World Evidence with Unstructured and Structured Data to Advance Tailored Therapy" (TRUST), was sponsored by the FDA Center for Drug Evaluation and Research.
As RWE is increasingly used to make clinical assertions and refine the standard of care, rigorous approaches are required to meet evidentiary standards. This three-year study will apply advanced RWE to a clinical scenario, and data quality will be studied by comparing traditional approaches (claims and health record structured data) to advanced approaches (deep phenotyping and data linkage). Differences in results will be measured to understand the extent to which data quality influences the resulting clinical assertions. Findings may inform future study design and definitions of fit-for-purpose data.
"Rigorous methodology and fit-for-purpose data are critical to ensure credible studies. High-quality real-world evidence can provide valuable insight for regulatory and clinical decision-making," said Jacqueline Corrigan-Curay, JD, MD, Director, Office of Medical Policy.
The study, FD-20-030, includes innovations in deep phenotyping, data linkage, and phenotype accuracy measurement. By studying data quality and demonstrating safe approaches to RWE, confidence can be increased in implementing RWE within regulatory and clinical pathways as a step toward personalized medicine, improved care, and more efficient care.
"We are excited to have FDA support to rigorously study high-accuracy RWE generation," said Dan Riskin, MD, FACS, CEO of Verantos and principal investigator. "This effort comes at a critical time, as regulators, payers, and providers are increasingly incorporating RWE insights into their decision-making processes. By studying data quality and demonstrating safe approaches to RWE, the country can move forward on solid footing."
Verantos (https://verantos.com) is the market leader in high-accuracy real-world evidence (RWE) generation. The Verantos RWE platform integrates heterogenous real world data sources and generates evidence with the accuracy necessary for regulatory and reimbursement use. The Verantos RWE platform leverages data science and artificial intelligence along with advanced data sources such as electronic health records (EHR) to generate RWE capable of supporting clinical assertions.