Rapid Signal Assessment Using Real World Data Solutions

Safety signal assessment is the process of evaluating a validated signal by considering all available relevant evidence from different sources to confirm or refute the event as an adverse drug reaction.

Signal assessment typically relies on analysis of pharmacovigilance databases, clinical trial data, and scientific literature. In addition to these sources, there may be a need to further evaluate the signal by conducting formal protocolized Real World Data (RWD) studies. These RWD studies can provide additional robust evidence. However, such studies are often resource and time-intensive, meaning that they are seldom feasible given signal assessment timelines.

To help address the resource and time constraints of traditional safety assessment, this initiative aims to evaluate current practice and identify novel opportunities to complement signal assessment with rapid RWD analyses. Furthermore, this initiative is offering a Framework for RSA and an Alternative to a Full Protocol.  Increasing use of RWD in safety signal assessments may bring awareness to potential safety issues sooner and thus promote patient safety and public health.