Bioethics Unit, Istituto Superiore di Sanità, Rome, Italy.
Clinical Research Department, FADOI Research Centre, Milan, Italy.
Front Public Health. 2022 Dec 15;10:1081150. doi: 10.3389/fpubh.2022.1081150. eCollection 2022.
Decentralized clinical trials (DCTs) are studies in which the need for patients to physically access hospital-based trial sites is reduced or eliminated. The CoViD-19 pandemic has caused a significant increase in DCT: a survey shows that 76% of pharmaceutical companies, device manufacturers, and Contract Research Organizations adopted decentralized techniques during the early phase of the pandemic. The implementation of DCTs relies on the use of digital tools such as e-consent, apps, wearable devices, Electronic Patient-Reported Outcomes (ePRO), telemedicine, as well as on moving trial activities to the patient's home (e.g., drug delivery) or to local healthcare settings (i.e., community-based diagnosis and care facilities). DCTs adapt to patients' routines, allow patients to participate regardless of where they live by removing logistical barriers, offer better access to the study and the investigational product, and permit the inclusion of more diverse and more representative populations. The feasibility and quality of DCTs depends on several requirements including dedicated infrastructures and staff, an adequate regulatory framework, and partnerships between research sites, patients and sponsors. The evaluation of Ethics Committees (ECs) is crucial to the process of innovating and digitalizing clinical trials: adequate assessment tools and a suitable regulatory framework are needed for evaluation by ECs. DCTs also raise issues, many of which are of considerable ethical significance. These include the implications for the relationship between patients and healthcare staff, for the social dimension of the patient, for data integrity (at the source, during transmission, in the analysis phase), for personal data protection, and for the possible risks to health and safety. Despite their considerable growth, DCTs have only received little attention from bioethicists. This paper offers a review on some ethical implications and requirements of DCTs in order to encourage further ethical reflection on this rapidly emerging field.
去中心化临床试验（DCTs）是指在研究中减少或消除患者实际访问医院试验点的需求。COVID-19 大流行导致 DCT 显著增加：一项调查显示，76%的制药公司、设备制造商和合同研究组织在大流行早期采用了去中心化技术。DCT 的实施依赖于数字工具的使用，如电子知情同意书、应用程序、可穿戴设备、电子患者报告结局（ePRO）、远程医疗，以及将试验活动转移到患者家中（如药物输送）或当地医疗保健场所（即社区为基础的诊断和护理设施）。DCT 适应患者的日常生活规律，通过消除后勤障碍，允许患者无论居住何处都能参与研究，提供更好地获取研究和试验产品的机会，并允许纳入更多样化和更具代表性的人群。DCT 的可行性和质量取决于几个要求，包括专用基础设施和人员、足够的监管框架以及研究机构、患者和赞助商之间的合作。伦理委员会（ECs）的评估对于临床试验的创新和数字化过程至关重要：ECs 需要评估工具和适当的监管框架。DCT 还引发了许多问题，其中许多具有相当大的伦理意义。这些问题包括对患者与医疗保健人员之间关系的影响、对患者社会层面的影响、对数据完整性（在源头、传输过程中、分析阶段）的影响、对个人数据保护的影响，以及对健康和安全可能产生的风险。尽管 DCT 有了相当大的发展，但生物伦理学家对它们的关注甚少。本文对 DCT 的一些伦理影响和要求进行了综述，以鼓励对这一快速发展的领域进行进一步的伦理思考。
