参与者作为分散临床试验的合作伙伴。

NEJM evidence Pub Date : 2025-09-01 Epub Date: 2025-07-09 DOI:10.1056/EVIDctw2500188
Paul A Harris, Alex C Cheng
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引用次数: 0

摘要

【摘要】分散式临床试验(dct)是指在医院或临床环境之外进行的试验,与传统的临床试验相比,它具有许多优势,如果操作得当,可以为研究人员、参与者和社会带来独特的好处。个人在家中远程参与的能力增加了便利性,但更重要的是,使参与审判的机会民主化,否则就会受到地理限制。由于dct中与参与者的个人互动减少,试验人员在为参与者制定招募、保留和回报价值的策略时必须有意识。将临床试验参与者作为dct的合作伙伴要求研究人员在试验的每个阶段考虑参与者的优先级。本文强调了支持dct所需的技术和程序考虑,并确定了试验创新的领域。通过使dct和技术平台以参与者为中心,并继续推进创新机会,研究人员可以加速科学发现,帮助参与者感到他们的贡献是有意义的,并培养对生物医学研究过程的长期信任。参见NEJM:轻度哮喘所需沙丁胺醇-布地奈德参见NEJM:您的组合哮喘吸入器-不要离开家而没有它!
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Participants as Partners in Decentralized Clinical Trials.

AbstractDecentralized clinical trials (DCTs), meaning those trials in which activities are conducted outside of hospital or clinic settings, offer many advantages over traditional clinical trials and, when properly operationalized, provide unique benefits to researchers, participants, and society. The ability of individuals to participate remotely from their homes adds convenience, but, more importantly, democratizes access to trials that would otherwise be limited by geographic constraints. As personal interactions with participants are diminished in DCTs, trialists must be intentional when strategizing recruitment, retention, and return of value for participants. Engaging clinical trial participants as partners in DCTs requires researchers to consider participant priorities at each stage of the trial. This article highlights technical and procedural considerations needed to support DCTs and identifies areas for trial innovation. By making DCTs and technology platforms participant centric and continuing to advance opportunities for innovation, researchers may accelerate scientific discovery, help participants feel their contributions are meaningful, and foster long-term trust in the biomedical research process.See also in NEJM: As-Needed Albuterol-Budesonide in Mild Asthma See also in NEJM: Your Combination Asthma Inhaler - Don't Leave Home without It!

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