de Jong Amos J, Zuidgeest Mira G P, Santa-Ana-Tellez Yared, Hallgreen Christine E, van Sloten Thomas T, de Boer Anthonius, Gardarsdottir Helga
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Drug Discov Today. 2025 Feb;30(2):104304. doi: 10.1016/j.drudis.2025.104304. Epub 2025 Jan 28.
Decentralized clinical trial (DCT) approaches - in which trial activities are conducted at participants' homes - have the potential to improve representativeness. We present a study that compared the demographics and cardiovascular risk factors of participants from a DCT (ASCEND) and a conventional trial with a similar trial objective (POPADAD) to those of patients in daily practice. We adjudicate that there are relevant differences when comparing the participants of the conventional trial and the DCT, with the latter providing better representativeness in terms of age, insulin use, smoking status, and body mass index, whereas conventional trial participants were more representative in terms of biological sex. Differences in these characteristics were not explained by the eligibility criteria, but are considered attributable to the operational trial approach.
去中心化临床试验（DCT）方法——即在参与者家中开展试验活动——有可能提高代表性。我们开展了一项研究，将一个DCT（ASCEND）和一个具有类似试验目标的传统试验（POPADAD）的参与者的人口统计学特征和心血管危险因素，与日常医疗中的患者进行比较。我们判定，在比较传统试验和DCT的参与者时存在显著差异，DCT在年龄、胰岛素使用情况、吸烟状况和体重指数方面具有更好的代表性，而传统试验参与者在生物学性别方面更具代表性。这些特征的差异并非由纳入标准所解释，而是被认为归因于试验的操作方法。
