The impact of operational trial approaches on representativeness: Comparison of decentralized clinical trial participants, conventional trial participants, and patients in daily practice

IF 6.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2025-02-01 DOI:10.1016/j.drudis.2025.104304

Amos J. de Jong , Mira G.P. Zuidgeest , Yared Santa-Ana-Tellez , Christine E. Hallgreen , Thomas T. van Sloten , Anthonius de Boer , Helga Gardarsdottir , the Trials@Home Consortium

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引用次数: 0

Abstract

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.

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操作试验方法对代表性的影响：分散临床试验参与者、常规试验参与者和日常实践患者的比较。

分散临床试验（DCT）方法——其中试验活动在参与者家中进行——具有提高代表性的潜力。我们提出了一项研究，比较了DCT （ASCEND）和具有相似试验目标的常规试验（POPADAD）与日常实践患者的参与者的人口统计学和心血管危险因素。我们判定，在比较传统试验和DCT的参与者时存在相关差异，后者在年龄、胰岛素使用、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理性别方面更具代表性。这些特征的差异不能用资格标准来解释，但被认为可归因于业务试验方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.