Whereas RCTs test what a treatment can do under ideal conditions, RWE reveals what it actually does across diverse patient populations in routine clinical practice. RWE is generated by analyzing sources such as medical claims (Mx), pharmacy claims (Rx), electronic health records (EHR) and patient registries. Regulatory agencies including the FDA increasingly accept RWE to support expanded indications, post-market surveillance and safety monitoring, making it a strategic priority for life sciences teams.