Trend 1 = RWE becomes embedded in regulatory systems and organisational structures

What’s changing: Regulators increasingly treat RWE as part of routine regulatory operations rather than as ad‑hoc support. This is reflected in the creation of dedicated organisational units, clearer internal processes, and formal integration of RWE into lifecycle oversight.

Seen in: FDA establishment of the Center for Real‑World Evidence Innovation; EMA/DARWIN EU expansion and integration with broader EU regulatory programmes; continued alignment of RWE activity with pharmacovigilance and post‑authorisation evidence generation.

So what? RWE is no longer peripheral. Organisations engaging regulators with RWE need consistent internal governance, defined ownership, and the ability to demonstrate how evidence is generated, maintained, and reused across the lifecycle.

Trend 2 = Health‑data access and interoperability move into implementation phase

What’s changing: Health‑data access initiatives transition from design and pilots into implementation planning, with clearer timelines, governance structures, and technical expectations.

Seen in: European Health Data Space (EHDS) legislative progress and implementation planning; HealthData@EU architecture discussions; DARWIN EU data catalogue growth and onboarding of additional data partners; national health‑data platform developments referenced across multiple jurisdictions.

So what? Data access becomes a programme‑level dependency. Feasibility increasingly hinges on understanding access bodies, permits, technical onboarding, and auditability requirements rather than simply identifying available datasets.

Trend 3 = Methodological expectations become more explicit and assessable

What’s changing: Regulators and networks move toward clearer articulation of what constitutes acceptable RWD quality and defensible RWE methods, particularly for regulatory and safety decision‑making.

Seen in: Draft EU Real‑World Data Quality Framework (RW‑DQF) consultation; continued EMA focus on transparency, pre‑specification, and documentation; alignment with CIOMS and ICH RWE‑related work streams.

So what? RWE is increasingly assessed against defined criteria rather than general principles. Teams need to demonstrate data fitness, analytical justification, and transparency in ways that are reviewable and repeatable.

Trend 4 = Data protection and cybersecurity obligations materially affect feasibility

What’s changing: Data protection and cybersecurity expectations expand and become more directly connected to research operations, vendor oversight, and contracting.

Seen in: National cybersecurity and data‑protection updates across Europe and beyond; early signals of NIS2‑related obligations affecting research service providers; clearer expectations around breach reporting, vendor assurance, and cross‑border transfer governance.

So what? Weak privacy or cybersecurity positioning can stop studies before they start. RWE programmes increasingly depend on controller/processor clarity, vendor readiness, and documented security controls.

Trend 5 = Operational standardisation tightens across ethics, contracts, and reporting

What’s changing: Regulators and health systems continue to standardise research operations through mandated templates, structured amendment processes, and defined reporting formats.

Seen in: UK IRAS replacement programme developments; continued evolution of UK model agreements and amendment processes; EU‑level coordination pilots; national implementation effects linked to MDR/IVDR and post‑market evidence expectations.

So what? Predictability improves, but flexibility declines. Organisations must track and apply the correct templates, systems, and process versions by jurisdiction to avoid delay and non‑compliance.