Bogas Mónica, Antas Joana, Magalhães Cátia, Revige Mafalda, Guerra Liliana, Ribeiro Cheila, Eça Rita Cunha, Nunes Filipa, Lopes Ana, Costa Luís, Gonçalves Mónica, Pedrosa Jorge, Capela Andreia, Gregório Tiago, Dias Patrícia, Alfaro Tiago, Pais Ana, Soares Rui, Queirós Ana, Torres Tiago, Assis Joana, Maia Joana, Ferreira Margarida, Horta Luís, Carreiro Rita, Almeida João, Meireles Maria João, Loução Carla, António Sofia, Lopes Catarina, Coelho Pedro, Costa Rita, Santana Margarida, Sousa Nuno
Roche Portugal, Amadora, Portugal.
AICIB - Agency for Clinical Research and Biomedical Innovation, Porto, Portugal.
Front Pharmacol. 2025 Apr 8;16:1578955. doi: 10.3389/fphar.2025.1578955. eCollection 2025.
Clinical studies are coordinated by multidisciplinary teams, which often lack adequate training and competencies. In this study, ROCHE and AICIB (Agency for Clinical Research and Biomedical Innovation) conducted a self-assessment survey aiming to evaluate the competency of clinical research professionals to conduct clinical research in Portugal and promote the identification of key actions to address priority gaps.
Clinical research professionals from 10 Portuguese centres answered an electronic survey, adapted and translated from the Joint Task Force for Clinical Trial Competency (JTFCTC) framework. Representatives of the centres, ROCHE and AICIB held a meeting to discuss the survey results, identify priority gaps and propose recommendations.
A total of 109 participants answered the questionnaire with the following national geographical distribution: North ( = 46), Centre Region ( = 16), and Lisbon metropolitan area ( = 47). A considerable proportion were Investigators (44.0%) and had more than 10 years of experience (34.9%). The eight JTFCTC Domains scored under 60% in the level of knowledge, with Investigators achieving overall higher scores. To address these gaps, key actions were proposed, such as enhancing training and educational opportunities, fostering collaboration and networking, and investing in infrastructure and resources.
This study was the first to assess clinical trial competency in Portugal, registering a high participation rate. The study highlights the need to develop a national plan of action, in a collaborative effort, between clinical research centres, universities, industry, regulatory authorities, national agencies, and patient organizations. This will not only contribute to elevate the quality of studies but also improve compliance with international standards, ultimately benefiting both researchers and patients.
临床研究由多学科团队协调开展，而这些团队往往缺乏足够的培训和能力。在本研究中，罗氏公司和临床研究与生物医学创新局（AICIB）开展了一项自我评估调查，旨在评估葡萄牙临床研究专业人员开展临床研究的能力，并推动确定解决优先差距的关键行动。
来自葡萄牙10个中心的临床研究专业人员回答了一项电子调查问卷，该问卷是根据临床试验能力联合工作组（JTFCTC）框架改编并翻译的。各中心的代表、罗氏公司和AICIB召开了一次会议，讨论调查结果，确定优先差距并提出建议。
共有109名参与者回答了问卷，其国家地理分布如下：北部（ = 46）、中部地区（ = 16）和里斯本大都市区（ = 47）。相当一部分是研究者（44.0%），且有超过10年的经验（34.9%）。JTFCTC的八个领域在知识水平方面得分低于60%，研究者的总体得分更高。为解决这些差距，提出了关键行动，如增加培训和教育机会、促进合作与网络建设以及投资基础设施和资源。
本研究是首次对葡萄牙的临床试验能力进行评估，参与率很高。该研究强调需要临床研究中心、大学、行业、监管机构、国家机构和患者组织共同努力制定一项国家行动计划。这不仅将有助于提高研究质量，还将改善对国际标准的遵守情况，最终使研究人员和患者都受益。
