IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Università Vita-Salute San Raffaele, Milan, Italy.
Clin Chem Lab Med. 2023 Jan 5;61(8):1388-1394. doi: 10.1515/cclm-2022-1184. Print 2023 Jul 26.
The traditional venue of clinical trials has been hospitals or specialized research units, usually requiring participants to come on-site. Although their contribution to biomedical progress is beyond dispute, they are characterised by two crucial logistical and ultimately scientifical limitations: poor retention and poor generalizability of results, as patients often have problems in concluding the investigation on-site. Remote Decentralised Clinical Trials (RDCTs) take advantage of digital technologies to design trial activities closer to the home of participants, with the aims of minimizing travel to health facilities and the risk of infections, improving the quality of life of participants and caregivers, reducing work absenteeism, including broader cohorts of patients and possibly reducing costs. RDCTs represent a minority of current global research, but the Covid-19 pandemic brought them to the fore. The authors of this paper promote the spread of RDCTs, building on early recommendations from international institutions, and provide some examples of their use and potential benefits in laboratory medicine.
传统的临床试验场所是医院或专门的研究单位，通常需要参与者到现场。尽管它们对生物医学进步的贡献无可争议，但它们具有两个关键的后勤和最终科学上的局限性：结果的保留率和普遍性较差，因为患者在现场完成调查往往存在问题。远程去中心化临床试验（RDCTs）利用数字技术设计更接近参与者家庭的试验活动，旨在最大程度地减少前往医疗机构的旅行和感染风险，提高参与者和护理人员的生活质量，减少工作缺勤，纳入更广泛的患者群体，并可能降低成本。RDCTs 目前仅占全球研究的一小部分，但新冠疫情使其成为焦点。本文作者在国际机构的早期建议的基础上，推动 RDCTs 的普及，并提供了一些实验室医学中使用和潜在益处的例子。
