优化西班牙的临床试验管理：carabela -临床试验框架整合了医疗模式和受试者经验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-09-01 DOI:10.1016/j.conctc.2025.101544

Carlos Almonacid , Borja G. Cosío , Xavier Muñoz Gall , Manuel Santiñà Vila , Jaime Signes-Costa , José Luis Velasco Garrido , Mercedes Luz , Marta Rodríguez , Alberto Godos , Ana Pérez Domínguez , Eunice Funenga , Carmen Moreno

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引用次数: 0

摘要

临床试验（CT）是评估新疗法安全性和有效性的框架。CARABELA-CT计划旨在通过提高效率、质量和受试者福祉来优化西班牙CT程序。为此，本文描述了CT医疗模式，确定了改进领域，提出了解决方案，并从CT受试者那里收集了重要的见解。CARABELA-CT采用三阶段方法。第一阶段涉及CT医疗模式的特征，包括西班牙六家试点医院的所有临床调查过程，确定改进领域和解决方案。第二阶段验证了这些发现，定义了关键的医疗质量指标。第三阶段侧重于传播和执行。此外，随机邀请7名CT受试者参加焦点小组，分享他们在沟通、协调和CT对生活质量影响方面的经验。确定了三种CT医疗保健模式，并根据访问、基础设施和资源进行了区分。确定了12个改进领域，导致38个解决方案，涉及学科教育、专业培训、组织、协议、资源和技术。建立了24项保健质量指标来监测CT过程。受试者体验强调了对更清晰的沟通、数字化信息和改进的受试者支持的需求，并揭示了参与CT的情感和心理益处，尽管存在挑战。CARABELA-CT提供了一个全面的框架，以加强西班牙CT过程。该计划整合了CT开发改进领域的潜在解决方案和相应的医疗质量指标，并优先考虑受试者体验，以提高效率、参与者参与度和可持续的、以患者为中心的临床研究模式。这些发现有助于持续改进CT管理，最终优化研究执行和医疗保健结果。

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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.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.