Trial of SiTes to IncreAse diversity in clinical TriaLs (TOTAL): A study protocol paper

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-01-01 Epub Date: 2025-11-09 DOI:10.1016/j.cct.2025.108141

Tenzin Yeshi Wangdak Yuthok , Anny D. Rodriguez , Victor Ritter , Erin Rose Cruz , Deidre A. Okeke , Farmaan Judge , Nicholas Vesom , Sa Shen , FeiFei Qin , Cati G. Brown-Johnson , Latha Palaniappan , Anekwe Onwuanyi , Eldrin Lewis

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引用次数: 0

Abstract

The Trial Of Sites to Increase Diversity in Clinical Trials (TOTAL) addresses the critical issue of underrepresentation in cardiometabolic clinical trials. Despite existing initiatives, disparities in trial participant racial and ethnic diversity persist, limiting the generalizability of findings and health equity. This study aims to evaluate the effectiveness of three diversity-enhancing recruitment strategies (DERS)—virtual community ambassadors, population-based research registries, and social media ads—compared to usual recruitment methods.

A hybrid implementation-effectiveness cluster RCT design will randomize 36 cardiovascular clinical trial sites across the US to one of these 4 arms. The main outcome assessed is the proportion of underrepresented participants pre- and during the intervention. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, the study will assess recruitment effectiveness for historically underrepresented participants. Data collection includes de-identified demographic, screening, and enrollment information analyzed through robust statistical methods, including logistic regression and generalized estimating equations. Qualitative interviews with site teams will provide additional insights into implementation challenges and successes.

The study aims to identify the most effective recruitment methods, refine these strategies, and disseminate findings to enhance future clinical trial diversity. The TOTAL study's findings will provide evidence-based recommendations for increasing representation in trials, addressing a long-standing barrier to equitable healthcare innovation. By improving diversity, TOTAL will contribute to the broader goal of ensuring that treatments are effective and safe for all populations, fostering inclusivity in scientific research, and advancing precision medicine. This research is supported by the American Heart Association, underscoring its importance in achieving health equity.

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增加临床试验多样性的地点试验（TOTAL）：一份研究方案文件。

增加临床试验多样性的试验（TOTAL）解决了心脏代谢临床试验中代表性不足的关键问题。尽管现有的举措，试验参与者的种族和民族多样性的差异仍然存在，限制了研究结果的普遍性和健康公平性。本研究旨在评估三种增强多样性的招聘策略（DERS）——虚拟社区大使、基于人口的研究登记和社交媒体广告——与通常的招聘方法相比的有效性。实施-有效性混合集群随机对照试验设计将在美国36个心血管临床试验地点随机分配到这4个组中的一个。评估的主要结果是干预前和干预期间未被充分代表的参与者的比例。使用RE-AIM（覆盖面、有效性、采用、实施和维护）框架，该研究将评估历史上代表性不足的参与者的招聘有效性。数据收集包括去识别的人口统计、筛选和入学信息，通过稳健的统计方法进行分析，包括逻辑回归和广义估计方程。与站点团队的定性访谈将为实现挑战和成功提供额外的见解。本研究旨在确定最有效的招募方法，完善这些策略，并传播研究结果，以增强未来临床试验的多样性。TOTAL研究的结果将为增加试验的代表性提供基于证据的建议，解决公平医疗创新的长期障碍。通过改善多样性，TOTAL将有助于实现更广泛的目标，即确保治疗对所有人群有效和安全，促进科学研究的包容性，并推进精准医学。这项研究得到了美国心脏协会的支持，强调了其在实现健康公平方面的重要性。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.