RWD can sharpen feasibility, sites, and protocol choices. It cannot replace a well-designed trial, and it should not be described as if it does.
Real-World Data is collected from sources associated with outcomes in everyday settings: registries, prescribing databases, and electronic medical records among them. Used well, it helps sponsors understand the context around a development programme — including how potential participants are distributed and how care is actually delivered.
Common applications include feasibility and patient profiling, site selection, protocol refinement, and, in some designs, support for a synthetic control discussion. Each of those uses has limits. Data quality, missingness, and coding practice vary by source. Regulatory use depends on the question being asked and the evidence standard that applies.
Ruisra discusses RWD as a research input: it can reduce avoidable complexity in a protocol and help teams choose sites with a clearer view of the available population. It does not, by itself, prove a therapy works.