Developing InnoVative Equity-focused Regulatory SciencE (DIVERSE)

项目摘要/摘要 通过临床试验和其他监管科学研究的多样性来促进健康公平 通过各种基于社区的招聘网站实现，并通过创新应用 参与学和适当的社区基础设施。这项建议建立在加州大学的基础上 马里兰州巴尔的摩(UMB)患者计划推进健康公平研究和科学的十年 与已建立的社区组织(CBO)合作伙伴关系的参与度(1) 沃尔格林，全国第二大社区药店网络和(2)Mt.黎巴嫩浸信会 (MLBC)，一个非裔美国人教会，一直是患者计划的长期合作伙伴。 穆林斯博士和患者计划推动了参与性科学的发展，这一科学建立在 团队科学的基本概念，但将“团队”扩展到包括非传统研究人员，如 患者、基于社区的提供者、社区健康倡导者、学习型健康系统管理员以及 参与科学调查的其他利益攸关方。包括并吸引更多元化的利益相关者团队是 作为一种融合多方利益相关者观点的方法而提出，这些观点可以协作和协同地 推进健康公平。在利用社区组织全面实施多样性倡议之前，重要的是 制作一份“概念证明”，以证明CBO有效地确定、招聘、转介、保留、 并在整个临床试验过程中不断吸引患者和相关利益相关者参与。我们的概念证明 是通过临床试验和其他卫生公平监管科学研究的模拟练习实现的 CBO地点。 建议的模拟练习与穆林斯博士的循证10步框架保持一致 耐心和利益相关者的参与。我们的模拟演习旨在评估是否以及如何 与CBO合作实现健康公平，以增强临床试验和其他监管科学的多样性 研究。为了实现这一首要目标，我们提出了以下三个目标：目标1：协作优先 健康公平模拟场景，以解决与健康公平相关的障碍和促进者 代表不足的人群参加临床试验和其他监管科学研究的情况 与2个社区组织合作：社区药房和宗教组织；目标2：开展和评价保健公平 模拟登记参加临床试验和其他卫生公平监管科学研究，以测试 CBO设置中的工作流，如临床试验和其他项目的登记、保留和传播站点 监管科学研究；目标3：评估和优先考虑以行动为导向的卫生公平活动，以加强 CBO解决与卫生公平相关的障碍和促进者并增加临床试验登记的能力 以及其他由代表性不足的人群进行的监管科学研究。

Project Summary/Abstract Advancing health equity through diversity in clinical trials and other regulatory science research can be achieved with diverse community-based recruitment sites when amplified with innovative application of the science of engagement and appropriate community infrastructure. This proposal builds on The University of Maryland Baltimore (UMB) PATIENTS Program’s decade of advancing health equity research and the science of engagement in collaboration with established community-based organization (CBO) partnerships with (1) Walgreens, the nation’s second largest network of community pharmacies and (2) Mt. Lebanon Baptist Church (MLBC), an African American church that has been a longstanding partner of the PATIENTS Program. Dr. Mullins and the PATIENTS Program have advanced the science of engagement, which builds upon fundamental concepts of team science but expands the “team” to include non-traditional researchers, such as patients, community-based providers, community health advocates, learning health system administrators, and other stakeholders in scientific investigations. Including and engaging a more diverse team of stakeholders is proposed as a means to incorporate multistakeholder perspectives that collaboratively and synergistically can advance health equity. Before full scale implementation of diversity initiatives using CBOs, it is important to produce a “proof of concept” to demonstrate the feasibility of CBOs to effectively identify, recruit, refer, retain, and continuously engage patients and relevant stakeholders throughout the clinical trial. Our proof of concept is achieved through simulation exercises of clinical trial and other health equity regulatory science studies in CBO locations. The proposed simulation exercises align with Dr. Mullins’ evidence based 10-Step Framework for Continuous Patient and Stakeholder Engagement. Our simulation exercises are designed to assess whether and how to partner with CBOs to achieve health equity to enhance diversity in clinical trials and other regulatory science research. To achieve that overarching goal, we propose three Aims as follows: Aim 1: Collaboratively prioritize health equity simulation scenarios to address health equity-related barriers and facilitators for underrepresented populations’ enrollment in clinical trials and other regulatory science research in partnership with 2 CBOs: community pharmacies and faith-based organizations; Aim 2: Conduct and evaluate health equity simulation of enrollment in clinical trials and other health equity regulatory science research to test feasibility of workflow in CBO settings as enrollment, retention, and dissemination sites for clinical trials and other regulatory science research; Aim 3: Evaluate and prioritize action-oriented health equity activities to enhance CBO capacity to address health equity-related barriers and facilitators and increase enrollment in clinical trials and other regulatory science research by underrepresented populations.