Romania on the Southeastern and Central European map of clinical research. Regional comparative study and the role of new digital tools in patient access to innovation

This paper analyzes the dynamics of the clinical research ecosystem across ten Central and South-Eastern European countries between April 1, 2023 and March 31, 2026, providing a comparative perspective on Romania’s performance. The results highlight a positive evolution for Romania, which, with a total of 793 identified clinical trials, is beginning to bridge the gap with regional leaders such as Poland and the Czech Republic. The analysis reveals a maturing local market through an increasing innovation index (the ratio of phase I and II trials), although a critical dependence on commercial funding persists (729 industrial sponsors versus four academic sponsors). Particular emphasis is placed on the utility of new digital tools developed under the CTIS regulatory framework. The EU Clinical Trials Map is presented as a strategic tool for monitoring research center density, while the national platform studiiclinice.anm.ro, launched by ANMDMR in 2024, represents a major innovation in public communication. By translating complex data into Romanian, this platform facilitates patient access to information regarding active trials, positioning the community pharmacy as a vital information hub. We conclude that the integration of these digital resources, coupled with expanding medical infrastructure, is essential for Romania to reach its potential as a regional hub of excellence in therapeutic innovation.