Optimising clinical trial management in Spain: The CARABELA-Clinical trials framework integrating healthcare models and subject experiences

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.