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132ANALESRANFwww.analesranf.comClinical Research with older adults. Characteristicsand trends in the European UnionSantiago Cu%u00e9llar Rodr%u00edguezan. r. acad. Farm.vol. 91. n%u00ba1 (2025) %u00b7 pp. 131-149Keywords Clinical researchClinical trialsOlder peopleEuropean UnionMethodologyReproducibilityel 75% de los estudios corresponden a las Fases II (exploratoria) y III(confirmatoria). Finalmente, los pa%u00edses de la UE con mayor n%u00famero de ensayoscl%u00ednicos actualmente son Francia (35,1% de los autorizados y 47,1% de los queest%u00e1n actualmente en marcha), Espa%u00f1a (32,3% y 47,7%), Alemania (22,8% y 39,2%)e Italia (25,5% y 37,3%), aunque gran parte de ellos son estudios multinacionales.En la mitad (50,4%) el promotor es una empresa farmac%u00e9utica, aunque tambi%u00e9nuna parte muy significativa (35,7%) est%u00e1 promovida por hospitales y cl%u00ednicas.abstraCtAging causes progressive physiological and pathological changes in all organs ofthe body, which determines the use of medications indicated in each particularcase. This is a primary reason for the representation of older adults in clinicaltrials because the behavior of drugs in a changing body tends to becomeunpredictable. Emerging evidence indicates an underrepresentation of olderadults in randomized clinical trials, which is not exclusive to certain countriesbut is widespread worldwide. This underrepresentation of older patients inclinical trials results in a lack of high-quality data for the care of this population,which is especially relevant given that older adults have, compared to theiryounger counterparts, a higher incidence of disease-related morbidities, takemore medications, and are responsible for more drug-related adverse events.The problem is exacerbated by the increasing life expectancy among people over65 in most countries around the world, and by the fact that nine-tenths of peopleover 65 are taking some form of medication, a proportion that rises even furtheramong those over 75.We conducted an analysis using data from the CTIS, the European Union%u2019s ClinicalTrials Information System (data extracted on March 7, 2025), corresponding toclinical trials involving people over 64 years of age that are authorized orcurrently ongoing. The total number of trials is 5,967, representing 78.5% of thetotal for all ages (7,600, from 0 to over 64 years). The number of ongoing clinicaltrials with completed recruitment and selection processes totals 1,405, of which39 (2.8%) had 1,000 or more participants, and only half (50.4%) included 100 ormore participants. The majority (43%) of these studies investigate neoplasticdiseases, with a significant majority being cardiovascular diseases (7.5%), thenervous system (6.6%), the immune system (6.6%), and the digestive system(6.0%). Considering the study phase, 75% of the studies correspond to Phase II(exploratory) and III (confirmatory). Finally, the EU countries with the highestnumber of clinical trials currently are France (35.1% of those authorized and47.1% of those currently ongoing), Spain (32.3% and 47.7%), Germany (22.8% and39.2%), and Italy (25.5% and 37.3%), although the majority of these aremultinational studies. Half (50.4%) are promoted by a pharmaceutical company,although a significant portion (35.7%) is also promoted by hospitals and clinics.