Real-World Evidence and Big Data SIG - International Society of Pharmacovigilance

Big data are defined as “extremely large datasets that may be complex, multi-dimensional, unstructured heterogeneous and which are accumulating rapidly and may be analyzed computationally to reveal patterns, trends, and associations”1.

A key source of big data is real-world data (RWD), defined as the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources (e.g. claims databases, electronic medical records, patients and disease registries) during routine clinical practice2. The evidence generated by these data, defined as real-world evidence (RWE), has become increasingly important in the regulatory field, to generate evidence in both the pre- and post-marketing setting as well as in the healthcare, clinical and scientific fields. Accordingly, regulatory agencies are delivering guidelines about how to integrate RWE in the process of approval of new medications.