5 Ways to Use Real-World AE Intelligence Posted July 23, 2015Enhanced PV: Pharmacovigilance teams are under pressure to increase both efficiency and effective – that is, they must review more data sooner, monitor more broadly and diligently across the drug lifecycle, and report more accurately. Real-world intelligence and signals can lead to improved insights as well as increased efficiency. It enables PV specialists to spend more time analyzing trends and focused on the most important signals and less time collecting, cleaning and managing data. Risk management: The long-term trends point toward greater transparency, with regulators expecting pharmas to know more and truly own product risks. That process starts with risk assessment and ranking. Real-world data can also help to create broad perspectives of drug safety across classes, with nuanced and dimensional visibility into specific drugs. Drug safety: If patient protection is the end, direct inputs based on the experience of actual patients are increasingly the means. In other words, more data about drug effects leads to better signals and – ultimately – safer drugs. In fact, drug safety is an increasingly digital discipline, with researchers, regulators and patients sharing information through social and online channels – that’s what’s made real-world intelligence accessible, timely and valuable. Focused research: By focusing researchers on the most likely demographic or epidemiological risks, and potential new indications, pharmas can streamline and optimize the design of large-scale studies – with high-potential opportunities prioritized appropriately. Post-marketing surveillance safety studies can also be useful in responding to regulators, as well as for optimizing phase IV clinical trials and other research. Product innovation: There is a well known history of happy accidents in the industry, but the process of discovering new potential indication can be advanced and enhanced through rigorous and ongoing cross-referencing of multi-sourced data sets. Insights from the real world can lead to innovation on several fronts – from repurposing medications based on unexpected side benefits, expanding the number of indications for existing drugs, and identifying unmet market needs.