dc.contributor
Institut Català de la Salut
dc.contributor
[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
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Almonacid, Carlos
dc.contributor.author
Cosio, Borja G
dc.contributor.author
Santiñà, Manuel
dc.contributor.author
signes-costa, jaime
dc.contributor.author
Velasco-Garrido, José Luis
dc.contributor.author
Muñoz, Xavier
dc.date.accessioned
2025-11-08T13:42:50Z
dc.date.available
2025-11-08T13:42:50Z
dc.date.issued
2025-11-07T10:52:40Z
dc.date.issued
2025-11-07T10:52:40Z
dc.identifier
Almonacid C, Cosío BG, Muñoz Gall X, Santiñà Vila M, Signes-Costa J, Velasco Garrido JL, et al. Optimising clinical trial management in Spain: The CARABELA-Clinical Trials framework integrating healthcare models and subject experiences. Contemp Clin Trials Commun. 2025 Dec;48:101544.
dc.identifier
http://hdl.handle.net/11351/14040
dc.identifier
10.1016/j.conctc.2025.101544
dc.identifier.uri
http://hdl.handle.net/11351/14040
dc.description.abstract
Clinical trial; Subject; Healthcare models
dc.description.abstract
Assaig clínic; Subjecte; Models d'atenció sanitària
dc.description.abstract
Ensayo clínico; Sujeto; Modelos de atención sanitaria
dc.description.abstract
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.
dc.description.abstract
This work was supported by AstraZeneca Farmacéutica Spain.
dc.format
application/pdf
dc.relation
Contemporary Clinical Trials Communications;48
dc.relation
https://doi.org/10.1016/j.conctc.2025.101544
dc.rights
Attribution 4.0 International
dc.rights
http://creativecommons.org/licenses/by/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Avaluació de resultats (Assistència sanitària)
dc.subject
Assaigs clínics
dc.subject
Assistència sanitària
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
dc.subject
HEALTH CARE::Health Services Administration::Patient Care Management::Delivery of Health Care
dc.subject
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
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
dc.subject
ATENCIÓN DE SALUD::administración de los servicios de salud::gestión de la atención al paciente::prestación sanitaria
dc.title
Optimising clinical trial management in Spain: The CARABELA-Clinical trials framework integrating healthcare models and subject experiences
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
