In a world where manufacturers must not only prove their product’s safety and efficacy prior to launch, but also ensure commercial success, real-world evidence (RWE) is crucial. Here, Dr Chitra Lele, chief scientific officer at Sciformix Corporation discusses the RWE’s continuum and how it could bridge the gap between clinical development and patient access.
bridging the gap
Real World Evidence (RWE) is defined by the FDA as ‘clinical evidence regarding the usage and potential benefits or risks of medical products derived from analysis of Real World Data (RWD)’.1RWD is the data collected from sources other than traditional clinical trials. These data are being obtained from electronic tracking systems used to capture patient experiences during care.