Real-World Evidence (RWE)
Clinical evidence derived from real-world data such as claims, EHRs, and registries, rather than a controlled trial.
Real-world evidence is clinical evidence drawn from real-world data: insurance claims, electronic health records, patient registries, and similar sources, rather than from a randomized controlled trial. It shows how a therapy performs across a broader, less controlled patient population than a trial's enrollment criteria would ever allow.
RWE doesn't replace trial data, it supplements it. Trials establish whether a drug works under controlled conditions. RWE answers a different question: how it performs once prescribed to the messier population of actual patients, with their actual comorbidities and actual adherence patterns. That makes it increasingly central to payer conversations and label-expansion arguments, and it's one of the evidence types that shows up most often in an AMCP dossier, where a payer's reviewers want to see how a therapy performs outside the trial setting it was approved in.