From Real-World Data to Decisions: Strengthening the Role of Real-World Evidence in Regulatory Frameworks

Real-world data (RWD) — drawn from electronic health records, insurance claims, patient registries, and wearable devices — is increasingly shaping how regulators, payers, and healthcare systems assess the safety and effectiveness of medicines. Yet translating this abundance of data into evidence robust enough to inform regulatory decisions remains a major challenge. Variability in data quality, inconsistent methodological standards, and differing acceptance criteria across jurisdictions continue to limit the confidence placed in real-world evidence (RWE) relative to traditional randomized controlled trials.This Research Topic invites contributions examining how RWD can be systematically converted into decision-grade RWE for regulatory use. We welcome studies addressing methodological approaches to strengthen causal inference from observational data, frameworks for assessing data quality and fitness-for-purpose, case studies of RWE informing label changes, post-marketing surveillance, or accelerated approvals, and comparative analyses of regulatory acceptance across regions (e.g., FDA, EMA, PMDA). Perspectives on harmonizing international standards and building trust in RWE among regulators, industry, and clinicians are also encouraged.By bringing together methodologists, regulators, and industry stakeholders, this collection aims to advance a shared understanding of how real-world evidence can reliably support regulatory decision-making and, ultimately, improve patient safety. Topic editors: MEHMET BURCU, Elisabetta Patorno Source: https://www.frontiersin.org/research-topics/84173/from-real-world-data-to-decisions-strengthening-the-role-of-real-world-evidence-in-regulatory-frameworks