Altems

Clinical research: Italia fourth in Europe but too slow in the enrolment phase

It took 148 days to identify patients and activate trials, 36 more than Spain: potential loss of 180 million for the NHS in 2022-2025

by Health Review

29 May 2026

Genetic research and Biotech science Concept. Human Biology and pharmaceutical technology on laboratory background. Radiologist using digital x-ray human body holographic scan projection 3D rendering. jittawit.21 - stock.adobe.com

4' min read

Translated by AI

Versione italiana

Key points

Project objectives
Evident gap with Spain
Accumulated delays

4' min read

Translated by AI

Versione italiana

Italia ranks fourth among European countries in terms of the total volume of clinical trials activated, but could climb the podium by overcoming organisational delays and operational criticalities that slow down its attractiveness for research. What weighs most heavily is the ability to enrol patients in international clinical trials: our country takes an average of 148 days to begin the actual enrolment phase, 36 more than Spain. The data are from the 2025 Report 'Missed Opportunities', carried out by the Laboratory on the Management of Clinical Trials of Altems - Alta Scuola di Economia e Management dei Sistemi sanitari of the Università Cattolica del Sacro Cuore on the Rome campus in collaboration with Farmindustria.

Experts have estimated that, on average, every 2.5 days of delay corresponds to one lost patient per study; overall, this translates into 10,540 fewer patients enrolled in our country over a period of three years, with a significant loss of competitiveness for the system. The observed lack of enrolment could have led to a potential loss of about 180 million euros for the SSN in the three-year period 2022-2025.

"Attracting clinical trials to Italia is a priority," says Marcello Cattani, President of Farmindustria. "First of all for citizens, who can quickly access innovative therapies through trials. Moreover, to strengthen the Italia ecosystem of research and public-private partnerships, as well as to offer professional growth opportunities to doctors and researchers. Every year in Italia, pharmaceutical companies invest over EUR 800 million in clinical research, often in National Health Service facilities. And they want to continue to do so because they believe in the many Italian excellences. A decisive step forward is needed, as the Altems study highlights, to reduce the time it takes to access innovation and make our nation increasingly competitive'.

Project objectives

The project, coordinated by Lab MSC Director Emmanouil Tsiasiotis, Project Manager Francesca Orsini and Statistical Analysis Coordinator Vincenzo Nardelli, represents one of the first experiences in Europe, and the first in Italia, of systematic use of the Clinical Trials Information System (CTIS), the platform introduced by European Regulation no. 536/2014 that collects public data on clinical trials authorised in member countries. Through this data infrastructure, the MSC Altems Laboratory has developed a comparative analysis of the Italian performance compared to the main European competitors - including Spain, Germany, France, Poland, Belgium and the Netherlands - along the entire 'trial journey': from regulatory authorisation to the activation of centres, from the start of enrolment to the closure of recruitment.

"This project," emphasises Emmanouil Tsiasiotis, director of Altems Lab Msc, "demonstrates how strategic it is to systematically collect and analyse clinical research data in order to transform them into useful evidence for the governance of the system. For the first time in Italia, we have used CTIS (Clinical Trials Information System) data, integrating them with operational data from companies, with the aim of measuring the country's competitiveness compared to other European systems. Our aim is to contribute to the development of a governance of clinical research based on shared KPIs (Key Performance Indicators), transparency and continuous benchmarking. In this path ALTEMS proposes itself as a strategic partner from a methodological, analytical and infrastructural point of view, supporting institutions, industry and experimental centres'.

Evident gap with Spain

The retrospective analysis examined approximately 1,100 multinational clinical trials conducted between 1 February 2022 and 30 June 2025, using public data extracted from the CTIS and operational data shared by the participating companies. To investigate enrolment dynamics, the project also integrated data from 126 studies and over 1,700 patients enrolled in Italia, provided by the participating companies.

The results confirm that Italia maintains a high level of attractiveness in terms of the number of clinical trials activated, ranking among the main European countries and in fourth place in terms of overall trial volume. However, the comparison with Spain shows a gap of around 450 clinical trials in the period analysed, despite an overlap of more than 75% of the multinational trial portfolio between the two countries.

According to the Report, the main critical element emerges in the operational phases following regulatory authorisation. In Italia, an average of more than 148 days elapse before the actual start of enrolment, about 36 days later than in Spain. Even after the formal activation of the centres, the Italia system requires additional days to recruit the first patient, thus compressing the useful recruitment window. The actual duration of the recruitment window in Italia is in fact shorter than that of its main European competitors, particularly in the cardio-metabolic, neurological and immunological areas.

These delays have a direct impact on the ability to recruit patients. Analyses show that Spain and Poland have the highest average levels of patients enrolled per study and the best performance in reaching planned targets, while Italia has lower values for both the average number of patients planned and the number of patients actually recruited.

Particularly relevant is the data on recruitment speed, calculated as the ratio of enrolled patients to the duration of the recruitment window. In phase III trials, the Italian speed is about half that observed in Spain, showing a significant competitive gap in the management of advanced phase trials.

The accumulated delays

To quantify the impact of these delays, ALTEMS developed a regression model based on aggregated data from phase III studies. The analysis shows a direct relationship between cumulative delay in the early stages of the 'trial journey' and reduced enrolment: on average, every 2.5 days of delay corresponds to one patient lost per study. Simulating a counterfactual scenario in which Italia had time performance comparable to Spain, the Report estimates that the Italian system could have enrolled approximately 10,540 more patients over the three-year period analysed.

The study also shows a strong territorial heterogeneity. Lombardy, Lazio and Emilia-Romagna are confirmed as the main Italian regions in terms of attractiveness and enrolment capacity, while other areas show significantly lower levels of participation in international multicentre studies.

The Report also links 'missed opportunities' to the economic impact of clinical research. According to analyses by the ALTEMS 'Averted Costs' project, every euro invested directly by pharmaceutical companies generates around three euros of indirect value for the National Health Service. Applying this model to the estimates of the 'Missed Opportunities' project, the observed missed enrolment could have resulted in a potential loss of approximately EUR 180 million over the three-year period 2022-2025.

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