2026-10-15T15:29:08Z https://api.figshare.com/v2/oai

oai:figshare.com:article/34513756 2026-10-14T17:31:25Z category_7 category_12 category_734 category_106 portal_5 item_type_3 month_year_10_2026

<p>Number of clinical trials in European countries.</p> Paolo Rocco (17224294) Valentina Pagella (25823464) Umberto M. Musazzi (25823467) Sara Manellari (25823470) Elena Paola Lanati (25823473) Paola Minghetti (3946373) Medicine Cell Biology Biological Sciences not elsewhere classified Science Policy primary therapeutic target heterogenous geographical distribution nervous system disorders mobile applications represent based medical devices 65 %), followed 254 eligible trials div >< p clinical trials registrations fund dtx research dtx clinical development clinical use psychiatric disorders italy represent based tools 32 %), development emerge dtx development virtual reality updated overview tr 11147 reimbursement policies regulatory priorities regulatory fragmentation primarily conducted prevalent technology paper provides north america namely psychiatric mostly indicated key factors january 2025 informing policy healthcare systems gov reveals gov </ fragmented policies expanding rapidly ethical issues digital therapeutics different capacity deliver evidence defined according comprehensive overviews clear direction cdigital therapeutics active countries 41 %) 20 %). <div><p>CDigital therapeutics (DTx) are software-based medical devices that deliver evidence-based therapeutic interventions directly to patients. While the clinical use of DTx is expanding rapidly, regulatory fragmentation and the absence of harmonized legal definitions hinder their assessment and reimbursement policies, as well as their integration into healthcare systems. There is currently a lack of comprehensive overviews of DTx clinical development, which are essential for informing policy, research and regulatory priorities. This paper provides an updated overview of randomised clinical trials involving DTx. 254 eligible trials on DTx, (defined according to ISO/TR 11147:2023) registered through January 2025 were identified through a search on C<i>linicalTrials.gov</i>. Mobile applications represent the most prevalent technology (65%), followed by web-based tools and virtual reality (20%). Psychiatric disorders are the primary therapeutic target (52% of the studies) with insomnia, depression, and anxiety being the most addressed conditions. Trials were primarily conducted in North America (41%) and Europe (32%), where Germany, Spain, and Italy represent the most active countries. The analysis of clinical trials registrations on ClinicalTrials.gov reveals a heterogenous geographical distribution of DTx development but also a clear direction in the type of conditions for which they are mostly indicated, namely psychiatric and nervous system disorders. The fragmented policies on DTx reimbursement, even among EU countries, and the different capacity of governments to fund DTx research and development emerge as key factors, along with cultural and ethical issues, in determining the willingness of the industry to invest in these devices.</p></div> 2026-10-14T17:31:14Z Dataset Dataset 10.1371/journal.pdig.0001750.t002 https://figshare.com/articles/dataset/_p_Number_of_clinical_trials_in_European_countries_p_/34513756 CC BY 4.0