Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings.

ABSTRACT: The evolving regulatory landscape has increasingly recognized the value of real-world data (RWD) in enhancing drug safety surveillance across the clinical development lifecycle. Enabled by frameworks such as the FDA's Real-World Evidence (RWE) Programs and other international regulatory bodies, sponsors now have expanded opportunities to use RWD to detect, evaluate, and manage safety signals in both pre- and post-market settings. This paper examines how the integration of RWD, particularly through privacy-preserving record linkage (PPRL) methods like tokenization, can improve pharmacovigilance by enabling longitudinal safety monitoring while protecting patient privacy. Traditional safety surveillance methods, such as spontaneous adverse event reporting and aggregate signal detection, are l

SUBMITTER: Gavin KM 

PROVIDER: S-EPMC12576344 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature