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Real-world evidence (RWE) has become a vital component of pharmaceutical decision-making, offering insights into how therapies perform in routine clinical settings beyond controlled trials. Medical Affairs plays a central role in collecting, analyzing, and interpreting real-world data (RWD) from sources such as electronic health records (EHRs), patient registries, claims data, and patient-reported outcomes (PROs). The integration of RWE with health economics and outcomes research (HEOR) provides a comprehensive evaluation of treatment value, informing regulatory approvals, reimbursement decisions, and clinical practice. With advancements in digital health and artificial intelligence (AI), the methodologies for RWE generation continue to evolve, improving data reliability and impact.

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Medical Affairs and Real-World Evidence

  • 章节

  • 发表日期：

    2025年

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  • Andriy Krendyukov

摘要

Real-world evidence (RWE) has become a vital component of pharmaceutical decision-making, offering insights into how therapies perform in routine clinical settings beyond controlled trials. Medical Affairs plays a central role in collecting, analyzing, and interpreting real-world data (RWD) from sources such as electronic health records (EHRs), patient registries, claims data, and patient-reported outcomes (PROs). The integration of RWE with health economics and outcomes research (HEOR) provides a comprehensive evaluation of treatment value, informing regulatory approvals, reimbursement decisions, and clinical practice. With advancements in digital health and artificial intelligence (AI), the methodologies for RWE generation continue to evolve, improving data reliability and impact.