{"id":35887,"date":"2026-05-19T10:05:00","date_gmt":"2026-05-19T08:05:00","guid":{"rendered":"https:\/\/askme.it\/insights\/real-world-evidence-ai-in-2026-from-regulatory-pilot-to-enterprise-practice\/"},"modified":"2026-05-28T17:55:03","modified_gmt":"2026-05-28T15:55:03","slug":"real-world-evidence-ai-in-2026-from-regulatory-pilot-to-enterprise-practice","status":"publish","type":"insights","link":"https:\/\/askme.it\/en\/insights\/real-world-evidence-ai-in-2026-from-regulatory-pilot-to-enterprise-practice\/","title":{"rendered":"Real World Evidence + AI in 2026: from regulatory pilot to enterprise practice"},"content":{"rendered":"
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The global market for Real World Evidence solutions was estimated by MarketsandMarkets at $5.43 billion in 2025 with a projection of $10.83 billion by 2030, a compound growth rate of 14.8%. The broader definition by Fortune Business Insights, which also includes services and data, brings the market value to 20 billion in 2025 with a trajectory to 65 by 2034. Pharma is the largest usage segment, around 45% in 2025. Behind the market numbers lies a structural change that Italian pharmaceutical companies are only beginning to recognize: Real World Evidence is no longer an asset to be built at the margin of a registration dossier, it is the evidential base on which regulatory, payer, and label-expansion decisions are made in 2026.<\/p>\n

The European infrastructure that makes all of this possible has a precise name: DARWIN EU. The federated network coordinated by EMA aggregates in 2025 thirty data partners, about 180 million patients, sixteen European countries, and has completed or initiated fifty-nine studies with year-on-year growth of 47.5%. The operational target is over 140 studies per year from 2025. The new competitive tender for the 2027-2032 period will be launched in the first half of 2026. For the European regulatory system it is a paradigm change: from dependence on randomized controlled trials as the only acceptable evidence for many decisions, to the structured integration of validated observational evidence.<\/p>\n<\/section>\n

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The closure of the regulatory framework<\/h2>\n

The third annual report of EMA’s RWE framework, published for the February 2024-February 2025 period, reports twenty-six scientific advice procedures in which Real World Evidence entered as a structured component. The reflection paper on Real World Data in non-interventional studies was adopted by the CHMP in March 2025 after about 700 public comments. On the U.S. side, the FDA finalized in August 2023 the guidance “Considerations for the Use of RWD and RWE to Support Regulatory Decision-Making for Drug and Biological Products” and in December 2025 published on the Federal Register the equivalent final guidance for medical devices, replacing the 2017 one.<\/p>\n

The convergent message from the two regulatory agencies is clear: Real World Evidence is accepted for label expansion, post-marketing surveillance, single-arm trials with external controls, and rare indications. It does not replace the randomized controlled trial for the initial registration decision in most NDA contexts. The gatekeeping criteria on which the authorities focus are three: relevance of the data to the regulatory question, reliability of sources, traceable provenance. It is the recognition of a methodological maturation that has required fifteen years and that today delimits a clear operational perimeter.<\/p>\n<\/section>\n

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Flatiron, IQVIA, Aetion: the three poles of the market<\/h2>\n

Flatiron Health has been a Roche subsidiary since 2018, acquired for $1.9 billion, and today operates on a network of about 260 U.S. community oncology clinics with fourteen of the top fifteen oncology companies as partners. In December 2025 Paradigm Health acquired Flatiron’s Clinical Research Business division, in an agreement that includes a multi-year cross-integration partnership. Roche does not separately report Flatiron’s revenue. IQVIA closed 2024 with $15.4 billion in total revenues, of which $6.16 billion in the Technology and Analytics Solutions division that includes Real World Evidence (+5.7%). IQVIA’s longitudinal data assets cover over 318 million insured lives in the United States. Aetion maintains active partnerships with FDA CDER and with its Office of Data, Analytics and Research, as well as collaborations with Sanofi and ICER, and is positioned by analysts among the three main regulatory-grade players together with Flatiron and TriNetX.<\/p>\n

OHDSI and its OMOP Common Data Model represent the technical interoperability standard that allows the players to speak to each other. A review published in 2024 identified 49 studies on OMOP in oncology alone; HIRA in South Korea has brought 10 million individuals under its K-OMOP; the European Health Data Space will push OMOP adoption in the next three years thanks to interoperability requirements. For Italian pharmaceutical companies planning their RWE architecture in 2026, choosing OMOP as the reference model significantly reduces the integration cost with DARWIN EU, with European partners, and with U.S. partnerships.<\/p>\n<\/section>\n

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AI unlocks unstructured data<\/h2>\n

The historical constraint that has slowed Real World Evidence has not been data availability but its extractability. EHRs, electronic health records, are predominantly composed of unstructured narrative notes; pathology reports and imaging reports contain crucial information in textual format; laboratory metadata require semantic normalization. For fifteen years this extraction has been done manually by clinical abstractors with costs that limited scale. The arrival of general-purpose LLMs and specialized models for the medical domain has reconfigured the economics: structured extraction of clinical endpoints from an oncology note is today an operation that takes seconds and cents, and performance on benchmarks has come close to that of the specialized medical abstractor.<\/p>\n

Mature RWE-AI workflows in 2026 combine three layers. NLP and LLM for the extraction of endpoints, biomarkers, adverse events, and lines of therapy from the narrative part of the EHR. Target trial emulation as a methodological framework to build a causal comparison from observational data. Synthetic control arm to provide comparison arms to single-arm trials in rare indications or advanced oncology. The platforms of Flatiron, IQVIA, Aetion, and the emerging specialists offer integrated packages on these three layers, and consulting vendors (Deloitte, ZS, EY) have developed dedicated practices.<\/p>\n<\/section>\n

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Italy: AIFA OsMed, the oncology registries, and the AIFA-AIOM table<\/h2>\n

The Italian Real World Evidence picture is more mature than public narrative suggests. Italian pharmaceutical expenditure in 2024, according to OsMed AIFA, was 37.2 billion (+2.8%), of which 72% public (26.8 billion, +7.7%). The 129 AIFA oncology registries monitored observationally between January 2013 and April 2023 accumulated 419,461 patient-indication pairings, against 87,452 in the corresponding pivotal trials. Italian real-world patients are on average 5.3 years older than trial patients. AIFA reactivated the RSO registry for observational studies on January 31, 2023 and updated its functionality in December 2025. In May 2026 AIFA and AIOM announced a joint table for the valorization of oncology registries as Real World Evidence assets for academic and industrial scientific research, with shared governance.<\/p>\n

For Italian pharmaceutical companies operating in 2026 the strategic message is clear: the Italian RWE infrastructure, built for fifteen years as a tool for controlling reimbursement, is becoming a scientific asset open to research. The transition is not automatic and requires an investment in methodology and governance, but the data base is richer than that of many European countries. The constraint to consider is that of the EU AI Act: when RWE-AI pipelines feed regulatory or post-authorization risk management decisions, they potentially fall within the high-risk regime applicable from August 2, 2026, with documentation, validation, and human supervision obligations that the governance design must incorporate from the outset. Real World Evidence and the AI Act are not separate domains in 2026. They are the same strategic problem.<\/p>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

DARWIN EU has brought 180 million patients under a single European federated infrastructure with 30 partners in 16 countries. Flatiron has been a Roche subsidiary since 2018. AIFA reactivated the RSO registry in 2023 and in May 2026 opened a joint table with AIOM. Real World Evidence has become structural for HTA, label expansion, and post-marketing.<\/p>\n","protected":false},"featured_media":35889,"menu_order":0,"template":"","insights_category":[968],"insights_tags":[920,918,919,921,917],"class_list":["post-35887","insights","type-insights","status-publish","has-post-thumbnail","hentry","insights_category-ai-and-pharma","insights_tags-aifa","insights_tags-darwin-eu","insights_tags-flatiron","insights_tags-ohdsi-omop","insights_tags-real-world-evidence"],"acf":[],"_links":{"self":[{"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/insights\/35887","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/insights"}],"about":[{"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/types\/insights"}],"version-history":[{"count":1,"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/insights\/35887\/revisions"}],"predecessor-version":[{"id":35888,"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/insights\/35887\/revisions\/35888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/media\/35889"}],"wp:attachment":[{"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/media?parent=35887"}],"wp:term":[{"taxonomy":"insights_category","embeddable":true,"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/insights_category?post=35887"},{"taxonomy":"insights_tags","embeddable":true,"href":"https:\/\/askme.it\/en\/wp-json\/wp\/v2\/insights_tags?post=35887"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}