Title : An overview of the impact of real-world data on signal detection
Abstract:
Signal Detection in pharmacovigilance is pivotal in understanding the benefit-risk profile of medicinal products throughout their life cycle. This is an evolving discipline and has undergone multiple changes driven by both new signal detection approaches and the availability of new data sets. Traditionally signal detection is based on evaluating data held in private safety databases and publicly available regulatory databases, e.g., FAERS. However, the rapid digitization of health records has resulted in the availability of Real-World Data (RWD) sets for analysis. While traditional approaches to signal detection have proven to be a reliable approach - they are not without their limitations, limitations that could be potentially be addressed by utilizing RWD.
RWD refers to raw data from various sources including electronic health records, claims data, patient registries, and other real-time records. Real-world evidence (RWE) is the evidence on a medical product's safety and efficacy that is generated using RWD. RWE presents us with an additional source of data for signal detection that may allow for more accurate and adaptable signaling.
The move towards RWE can facilitate the identification of signals in a larger and more diverse patient population, enabling a more realistic evaluation of a drug's benefit-risk profile when used in real-world settings. Additionally, RWD and RWE may allow for the quicker detection of safety signals than those identified through traditional approaches outlined above. Using technological advances, RWD & RWE can transform signal detection into a more proactive discipline and in doing so bring real benefit to all stakeholders involved.
This presentation looks at the benefits RWD & RWE can bring to signal detection in pharmacovigilance and asks, as a source, what it brings that others do not in understanding benefit-risk profiles in medicinal products. Furthermore, this presentation aims to determine what approaches can be adopted to best evaluate RWD & RWE in the context of detecting signals.
Audience Take Away Notes:
- The Benefit of using RWD in signal detection
- What RWD brings that traditional methodologies do not
- Approaches for utilizing RWD & RWE evidence for signal detection