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External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms
Session Chair(s)
Mayur Saxena, PHD
Chief Executive Officer, Droice Labs, United States
The focus of the panel is to understand how to use RWD in clinical trials so that it can be relied upon as core evidence for regulatory decisions, including external control arms (ECAs), hybrid or pragmatic clinical trials, and RWD powered covariate adjustment. For RWD to be used in a clinical trial, the processes to prepare RWD require the same scale and rigor as global multicenter trials, where evidence is generated in a harmonized, coordinated, and systematic way across geographies, sites, and data sources. Even with access to relevant RWD, the messy nature of the data results in data processing delays, low-quality data, and ultimately a lack of trust in analytical results by the regulator. This panel will address the biggest challenges for accepting RWD as core evidence, which include ensuring data relevance, quality, reliability, and scalable data validation, as well as strategies to scale up RWD preparation from ad hoc projects to enterprise-level machinery for pharma.
Learning Objective : Explore strategies to address the inherent challenges of real-world data (RWD) preparation at scale for external control arms (ECAs), including data scalability and quality; Describe how to transition from ad hoc ECA projects to an enterprise-level approach that ensures data quality, processing efficiency, and trustworthiness in analytical results for pharma clinical development.
Speaker(s)
Industry Update
Executive Director, Center for Observational Research, Amgen Inc, United States
Industry Update
Director/ Senior Research Fellow, AbbVie, United States
Industry Update
Executive Regulatory Science Director , AstraZeneca, United States
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