REAL-WORLD EVIDENCE GENERATION IN ITALY: A COMPARATIVE ANALYSIS BASED ON THE HMA-EMA CATALOGUE OF REAL-WORLD DATA STUDIES
Author(s)
valentina drago, PhD1, Maria Laura Di Salvo, M.Pharm1, Federica Greco, MSc1, Filippo Drago, PhD2.
1SCF, Catania, Italy, 2Centre for Research and Consultation in HTA and Drug Regulatory Affairs (CERD), University of Catania, Catania, Italy.
1SCF, Catania, Italy, 2Centre for Research and Consultation in HTA and Drug Regulatory Affairs (CERD), University of Catania, Catania, Italy.
OBJECTIVES: The HMA-EMA Catalogue of real-world data (RWD) studies serves as centralized global repository, enhancing research transparency and supporting investigations. While global trends are well-documented, a country-specific evaluation is essential to understand national research strategies. This study characterizes Italy’s real-world evidence (RWE) landscape, assessing its volume, therapeutic focus, and operational characteristics compared to other countries.
METHODS: A comprehensive Excel database including 3367 RWD studies was developed from the HMA-EMA Catalogue. Key variables were collected and analysed: actual study start year, population ages, geographical distribution, regulatory mandate status, study duration, national fundings, and therapeutic areas. To contextualize Italy’s position, an heatmap was generated for countries exceeding 200 registered studies, cross-referencing geographic origin with therapeutic areas.
RESULTS: Analysis of chronological trend in Italy revealed a progressive increase in started studies over the analysed period (1997-2026), reaching two significant peaks in 2016 (n=57) and in 2020 (n=64). Only one study received national fundings. Among 3367 studies, Italy emerged as a prominent contributor (sixth position) within the high-volume country cluster (>200 studies), with n=723 registered studies. Accordingly with global trend results, the adult studies (n=449) outnumbered paediatric (n=26) and mixed-ages ones (n=215). The heatmap analysis demonstrated distinct regional patterns across clinical categories, with countries highlighting a uniform distribution across main therapeutic areas (i.e. UK, Germany, Spain) and others with different research concentrations (i.e. France, USA, Italy). Specifically, Italian RWE production was heavily concentrated in oncology and infectious diseases studies.
CONCLUSIONS: Italy represents a key player in the RWE landscape, characterized by high-volume output but highly polarize research topics. The strong concentration in oncology is in line with the trend of global therapeutic priorities along with specialized infrastructures, but also potential research gaps in other clinical areas. These findings offer valuable insights for stakeholders to optimize Italian future RWD investments and landscape.
METHODS: A comprehensive Excel database including 3367 RWD studies was developed from the HMA-EMA Catalogue. Key variables were collected and analysed: actual study start year, population ages, geographical distribution, regulatory mandate status, study duration, national fundings, and therapeutic areas. To contextualize Italy’s position, an heatmap was generated for countries exceeding 200 registered studies, cross-referencing geographic origin with therapeutic areas.
RESULTS: Analysis of chronological trend in Italy revealed a progressive increase in started studies over the analysed period (1997-2026), reaching two significant peaks in 2016 (n=57) and in 2020 (n=64). Only one study received national fundings. Among 3367 studies, Italy emerged as a prominent contributor (sixth position) within the high-volume country cluster (>200 studies), with n=723 registered studies. Accordingly with global trend results, the adult studies (n=449) outnumbered paediatric (n=26) and mixed-ages ones (n=215). The heatmap analysis demonstrated distinct regional patterns across clinical categories, with countries highlighting a uniform distribution across main therapeutic areas (i.e. UK, Germany, Spain) and others with different research concentrations (i.e. France, USA, Italy). Specifically, Italian RWE production was heavily concentrated in oncology and infectious diseases studies.
CONCLUSIONS: Italy represents a key player in the RWE landscape, characterized by high-volume output but highly polarize research topics. The strong concentration in oncology is in line with the trend of global therapeutic priorities along with specialized infrastructures, but also potential research gaps in other clinical areas. These findings offer valuable insights for stakeholders to optimize Italian future RWD investments and landscape.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD191
Topic
Methodological & Statistical Research, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Distributed Data & Research Networks
Disease
No Additional Disease & Conditions/Specialized Treatment Areas