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临床研究载体作为医学研究教育和开展去中心化试验的一种方式,支持研究中的公平、公正和多样性。

Clinical research vehicles as a modality for medical research education and conduct of decentralized trials, supporting justice, equity, and diversity in research.

作者信息

Moore Kenneth T

机构信息

Johnson & Johnson Innovative Medicine, Titusville, New Jersey, USA.

出版信息

Bioethics. 2025 Feb;39(2):213-220. doi: 10.1111/bioe.13360. Epub 2024 Oct 3.

Abstract

Current clinical research lacks diversity in those that participate. This lack of diversity is concerning given its importance for successful drug development. The frequency and severity of many diseases, along with the pharmacological properties of therapies, can display significant differences based on patient diversity. A clinical trial population that is more reflective of these differences will help researchers better understand the therapeutic profile of the treatment and provide generalizable knowledge to the medical community. The advent of decentralized clinical trial designs is meant to help address this lack of diversity by using portable digital health technologies and virtual interactions to enhance clinical trial access and broaden participation. By leveraging these technologies, trial conduct can occur at locations other than traditional research sites. This shift in trial location may help address some of the logistical, educational, engagement, and trust barriers that have historically prevented enrollment of diverse populations. However, these types of trials still have limitations. Ethical concerns around justice, equity, and diversity will still exist with decentralized clinical trials, which could be mediated using clinical research vehicles. When utilized, this modality may enhance the scientific design and conduct of clinical trials and better follow these ethical principles. These enhancements and improved ethical direction could be accomplished through increasing community involvement, improving health literacy, supporting more diverse trial sites, creating community-based research footholds, fostering connections with researchers, limiting technical challenges, and preventing data security issues.

摘要

当前的临床研究在参与者方面缺乏多样性。考虑到其对成功药物研发的重要性,这种多样性的缺乏令人担忧。许多疾病的发病率和严重程度,以及治疗方法的药理学特性,可能会因患者的多样性而呈现出显著差异。一个更能反映这些差异的临床试验群体将有助于研究人员更好地了解治疗方法的治疗概况,并为医学界提供可推广的知识。去中心化临床试验设计的出现旨在通过使用便携式数字健康技术和虚拟互动来增强临床试验的可及性并扩大参与度,从而帮助解决这种多样性的缺乏。通过利用这些技术,试验可以在传统研究地点以外的地方进行。试验地点的这种转变可能有助于解决一些在历史上阻碍了不同人群参与试验的后勤、教育、参与度和信任方面的障碍。然而,这类试验仍然存在局限性。去中心化临床试验中围绕公平、公正和多样性的伦理问题依然存在,这些问题可以通过临床研究载体来进行调解。当采用这种方式时,它可能会加强临床试验的科学设计和实施,并更好地遵循这些伦理原则。这些改进和更好的伦理指导可以通过增加社区参与、提高健康素养、支持更多样化的试验地点、建立基于社区的研究立足点、促进与研究人员的联系、限制技术挑战以及防止数据安全问题来实现。

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