Real-world evidence in 2026: from post-approval safety to strategic decisions
RWE has moved well beyond post-approval monitoring. Where regulators and industry now accept real-world data to inform design, comparators and access, and where the limits still sit.
Insight · · 1 min
For a decade, real-world evidence lived downstream, a post-approval safety obligation, useful but peripheral to the pivotal trial. That framing is now outdated. Regulators across the EU and US increasingly accept fit-for-purpose real-world data earlier in the lifecycle: to characterise natural history, to build external comparators where randomisation is impractical, and to inform feasibility and endpoint selection before a protocol is locked. The shift is not that RWE has become 'as good as' a trial, it hasn't, and conflating the two damages credibility. The shift is that the question has become more precise: for this decision, with this data, under this governance, is the evidence fit for purpose? Answering it well requires provenance you can defend, a methodology that confronts confounding and missingness head-on, and transparency about limitations. At Evidilya, we treat RWE as a design discipline, not a data dump, which is why our real-world studies start from the regulatory or payer decision they must support, and work backwards to the data and the method.
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