Leveraging Real-World Evidence in Pharmacovigilance Reporting

Abstract

The real-world evidence (RWE) has emerged as significant to strengthen the pharmacovigilance reporting and to understand the safety and efficacy profile of the drugs in the uncontrolled populations other than trial participants. This article focuses on the possibilities of using RWE to enhance the analysis of monitored drugs’ safety and the decision-making of the regulatory agencies. And highlights the use of information from the electronic health records, patient registries and social media to better detect and study ADRs. Through the use of big data analysis and AI, RWE makes it possible for the identification of ADRs that may not manifests itself during the clinical trial period. From this article, concerns related to RWE are also discussed with regard to data quality, privacy, and the necessity for the consistency of methods and protocols in the use of RWE on the field of pharmacovigilance practices. In addition, it emphasises that RWE can be valuable in enabling risk management and directing the actions of the regulators to improve patient safety. This review therefore supports the integration of real-world evidence into the structure of pharmacovigilance in order to have a more progressive model to the existing safety program. The application of real data by the health care providers and regulators can therefore assist in coming up with the correct measures to protect the public.