RWD, RWE and Pain Big Data – What is the difference?

Real world data (RWD) involves data collected outside of clinical studies and their scientific constraints. It often comes from EHR,  EMR, registries, and claims data.  Yet, it is often been ignored over trial data. That is, until recently, when ‘big data’ became a household manta.

What is amazing about RWD is that it produces real world evidence (RWE) that is truly representative of live disease progression, patient cases, device or drug experience and patient impact.  It can tell stories at the patient level, practice level, life science level and more. RWE is incredibly actionable when powered by analytics, machine learning & artificial intelligence (AI). It provides insight beyond traditional time-delayed clinical trial data, making it possible to use RWD to support real-time care planning, disease hot-spotting and even post-market clinical reporting.

Moreover, there is the potential to link data from different sources; improve trial efficiency; identify new indications, and a real-world perspective of risks/benefits to make informed decisions beyond traditional clinical trials. RWE also has regulatory and market impact including the updated FDA guidelines requiring RWE use in regulatory decisions and how AI and information exchange can be securely managed. There are ethical and privacy concerns, recent big data consent guidelines and best practices for clinically integrating RWD in the form of data aggregation and more.  Watch for our Data Team to talk more about how RWD can morph into RWE for those in the pain community seeking real-time use of RWD, its evidence and ultimate data storytelling.