COMmunity Mistrust and Institutional Trustworthiness to advance health EQuity research (COMMIT-EQ)

项目摘要/摘要 这项提案回应了FDA推动种族和少数族裔参与 新冠肺炎/新冠肺炎变异临床试验和/或有助于告知继续 FDA批准的产品(治疗学、诊断学和 疫苗)或受EUA/EUA扩展的产品，用于治疗、预防或 新冠肺炎的诊断(RFA-FD-22-003)。我们是唯一有资格与FDA合作的公司 因为我们几十年来的健康差距和健康公平研究，包括身份识别 与社区临床试验和研究中代表性不足有关的因素- 学术伙伴关系。在新冠肺炎大流行期间，不一致且交付不力 顶尖科学家和政策制定者的沟通，以及持续的健康不平等 在非裔美国人社区，特别是巴尔的摩的经验继续 使不信任感持久存在，从而降低参与临床护理和 研究。为了解决这些根本原因，学术和其他研究机构和卫生 护理系统必须改变他们的视角，不再只关注改变 服务不足和弱势群体。推进新冠肺炎临床试验中的健康公平 极具挑战性，但在社区指导下开展活动时是可以实现的 研究障碍/因素以及与历史上积极可信的伙伴关系 代表性不足的社区。通过我们的社区参与研究(CENR) 与非裔美国人教堂、社区药房和社区咨询机构建立伙伴关系 董事会，我们建议的研究将共同开发一个以股权为重点的实用战略工具包和 促进将公平纳入临床试验方案开发的规划的资源 并付诸实施。 通过与社区和社区药房合作伙伴的合作，我们的目标是： 目标1：说明以前报告的和新出现的障碍和促进者对健康的影响 非洲裔美国人参与新冠肺炎临床试验研究的股权。 目标2：共同设计注重健康公平的原则，支持社区参与的研究 (Cenr)建立伙伴关系，促进试行登记，并包括社区组织，如 非裔美国人教堂、社区药房和研究密集型机构。 目标3：共同开发工具包，促进以公平为重点的新冠肺炎临床试验研究 招聘、保留和实施协议。

PROJECT SUMMARY/ABSTRACT This proposal responds to the FDA’s desire to advance racial and ethnic minority participation in COVID-19/COVID-19 variant clinical trials and/or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) or products subject to EUAs/EUA expansion for the treatment, prevention, or diagnosis of COVID-19 (RFA-FD-22-003). We are uniquely qualified to collaborate with the FDA because of our decades of health disparities and health equity research, including identification of factors associated with under-representation in clinical trials and research on community- academic partnerships. During the COVID-19 pandemic, inconsistent and poorly delivered communication by leading scientists and policy makers, and continued health inequities experienced in the African American community, and Baltimore in particular, continue to perpetuate the feelings of mistrust that reduces willingness to participate in clinical care and research. To address these root causes, academic and other research institutions and health care systems must shift their lens from one that focuses solely on changing behaviors among underserved and vulnerable populations. Advancing health equity in COVID-19 clinical trials is extremely challenging, yet achievable when activities are informed by community guided research on barriers/factors as well as active and authentic partnerships with historically underrepresented communities. Through our Community-Engaged Research (CEnR) partnerships with an African American church, community pharmacy, and community advisory board, our proposed study will co-develop an equity-focused toolkit of practical strategies and resources to promote planning for incorporation of equity in clinical trial protocol development and implementation. In collaboration with community and community-based pharmacy partners, our Aims are: Aim 1: Delineate which previously reported and emerging barriers and facilitators impact health equity for African American participation in COVID-19 clinical trials research. Aim 2: Codesign health equity-focused principles that support Community-Engaged Research (CEnR) Partnerships to foster trial enrollment and include community organizations, such as African American churches, community pharmacies, and research-intensive institutions. Aim 3: Codevelop a toolkit to facilitate equity-focused COVID-19 clinical trial research recruitment, retention, and implementation protocols.