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促进临床试验的多样性:规划针对美国历史上代表性不足的早期症状性阿尔茨海默病患者群体的“校友广告”(ALUMNI AD)研究的见解。

Promoting diversity in clinical trials: insights from planning the ALUMNI AD study in historically underrepresented US populations with early symptomatic Alzheimer's disease.

作者信息

Wise-Brown Alexandria, Brangman Sharon A, Henderson J Neil, Willis-Parker Monica, Monroe Stephanie, Mintzer Jacobo E, Grundman Michael, Smith Janice, Doody Rachelle S, Lin Helen, Assman Beverly, Rippon Gregory A, Gonzales Rozanno, Assunção Sheila Seleri

机构信息

Genentech, Inc., a member of the Roche Group, US Medical Affairs, South San Francisco, CA, USA.

Department of Geriatrics, SUNY Upstate Medical University, Syracuse, NY, USA.

出版信息

EClinicalMedicine. 2024 Jul 13;73:102693. doi: 10.1016/j.eclinm.2024.102693. eCollection 2024 Jul.

Abstract

UNLABELLED

Clinical trial participation across disease areas, including Alzheimer's disease (AD), has been biased towards White participants of European ancestry. To support clinical decision-making across diverse populations, we must recognize and address barriers to trial participation. To inform the design of ALUMNI AD, a trial focused on historically underrepresented AD populations, we held advice-seeking fora with key stakeholders to understand barriers and identify potential solutions to maximize trial participation of underrepresented racial and ethnic groups in the US. Strategies identified from this process include: obtaining and implementing recommendations from community stakeholders; establishing a simple and inclusive prescreening and screening process; supporting participants and care partners; identifying and activating community-centric clinical sites; and demonstrating community commitment. While ALUMNI AD did not commence, we hope that our insights could be incorporated into future studies to improve diversity, equity, and inclusion in AD clinical research.

FUNDING

This study was sponsored by Genentech, Inc.

摘要

未标注

包括阿尔茨海默病(AD)在内的跨疾病领域的临床试验参与情况一直偏向于欧洲血统的白人参与者。为了支持针对不同人群的临床决策,我们必须认识并解决试验参与的障碍。为了为聚焦于历来代表性不足的AD人群的ALUMNI AD试验设计提供信息,我们与关键利益相关者举行了咨询论坛,以了解障碍并确定潜在解决方案,以最大限度地提高美国代表性不足的种族和族裔群体的试验参与率。从这一过程中确定的策略包括:获取并实施社区利益相关者的建议;建立简单且包容的预筛选和筛选流程;支持参与者和护理伙伴;识别并激活以社区为中心的临床站点;以及展现社区承诺。虽然ALUMNI AD试验尚未启动,但我们希望我们的见解能够纳入未来的研究,以改善AD临床研究中的多样性、公平性和包容性。

资金

本研究由基因泰克公司赞助。

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