Sistema de Salut de Catalunya
Institut Català de la Salut
[Almonacid C] Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain. [Cosío BG] Son Espases University Hospital-IdISBa and CIBERES, Palma de Mallorca, Spain. [Muñoz Gall X] Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Santiñà Vila M] Spanish Society for Healthcare Quality, Oviedo, Spain. [Signes-Costa J] Clínico University Hospital, INCLIVA, El Pla Del Real, Valencia, Spain. [Velasco Garrido JL] Virgen de La Victoria University Hospital, Puerto de La Torre, Málaga, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-11-07T10:52:40Z
2025-11-07T10:52:40Z
2025-12
Clinical trial; Subject; Healthcare models
Assaig clínic; Subjecte; Models d'atenció sanitària
Ensayo clínico; Sujeto; Modelos de atención sanitaria
Clinical trials (CT) are the framework upon which novel treatments' safety and efficacy are assessed. The CARABELA-CT initiative aims to optimise Spanish CT procedures by improving efficiency, quality, and subject well-being. To this, it characterised CT healthcare models, identified improvement areas, proposed solutions, and gathered important insights from CT subjects. CARABELA-CT took a three-phase approach. Phase I involved CT healthcare models’ characterisation, including all clinical investigation processes in Spain, across six pilot hospitals, identifying improvement areas and solutions. Phase II validated these findings, defining key healthcare quality indicators. Phase III focused on dissemination and implementation. Additionally, seven randomly invited CT subjects participated in a focus group to share their experiences regarding communication, coordination, and CT impact on quality of life. Three CT healthcare models were identified, distinguished according to access, infrastructure, and resources. Twelve improvement areas were defined, leading to 38 solutions addressing subject education, professional training, organisation, protocols, resources, and technology. Twenty-four healthcare quality indicators were established to monitor CT processes. Subject experiences highlighted the need for clearer communication, digitalised information, and improved subject support, and revealed the emotional and psychological benefits of CT participation, despite the challenges. CARABELA-CT provides a comprehensive framework to enhance Spanish CT processes. This initiative integrates potential solutions in improvement areas in CT development and the corresponding healthcare quality indicators, and prioritises subject experiences to foster efficiency, participant engagement, and a sustainable, patient-centric clinical research model. These findings contribute to the continuous improvement of CT management, ultimately optimising research execution and healthcare outcomes.
This work was supported by AstraZeneca Farmacéutica Spain.
Article
Published version
English
Avaluació de resultats (Assistència sanitària); Assaigs clínics; Assistència sanitària; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; HEALTH CARE::Health Services Administration::Patient Care Management::Delivery of Health Care; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios clínicos como asunto::ensayos clínicos como asunto; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento; ATENCIÓN DE SALUD::administración de los servicios de salud::gestión de la atención al paciente::prestación sanitaria
Elsevier
Contemporary Clinical Trials Communications;48
https://doi.org/10.1016/j.conctc.2025.101544
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3396]
