More companies are realizing the value real-world evidence (RWE) – the clinical evidence regarding the potential benefits or risks of a therapy generated from data relating to patient health or the delivery of health care – can add at every stage of a therapy’s lifecycle. RWE can not only help companies better understand a product’s safe and appropriate use in a post-approval setting, but the data can also inform innovation, trial design, personalized medicine, regulatory filings and optimize decision-making for better patient outcomes.
But, as the demand for use of RWE increases, we must ask ourselves “Are we doing all that we can...