Developing InnoVative Equity-focused Regulatory SciencE (DIVERSE)

发展以股权为中心的创新监管科学（多元化）

• 批准号: 10838240
• 负责人: C. DANIEL MULLINS
• 金额: $ 25万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10838240
• 关键词: Developing; InnoVative; Equity; focused; Regulatory

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.

项目总结/摘要 通过临床试验和其他监管科学研究的多样性促进健康公平， 通过各种基于社区的招聘网站实现，并通过创新应用 参与科学和适当的社区基础设施。这一建议建立在大学的基础上， 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伙伴关系协作，与（1） 沃尔格林，全国第二大社区药店网络和（2）山。黎巴嫩浸信会 （MLBC），一个非裔美国人教会，一直是病人计划的长期合作伙伴。 博士马林斯和病人计划推进了参与科学，这是建立在 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，例如 患者、社区医疗服务提供者、社区健康倡导者、学习型卫生系统管理者，以及 科学研究中的其他利益相关者。包括和参与更多样化的利益相关者团队， 作为一种手段，纳入多方利益攸关方的观点，通过合作和协同作用， 促进健康公平。在利用社区组织全面实施多样性倡议之前， 制作“概念证明”，以证明社区组织有效识别、招聘、推荐、留住 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。我们的概念验证 是通过临床试验和其他健康公平监管科学研究的模拟练习来实现的， CBO地点 拟议的模拟练习与Mullins博士的基于证据的10步框架相一致， 患者和利益相关者的参与。我们的模拟练习旨在评估是否以及如何 与社区组织合作，实现健康公平，增强临床试验和其他监管科学的多样性 research.为了实现这一总体目标，我们提出了以下三个目标：目标1： 卫生公平模拟情景，以解决卫生公平相关的障碍和促进因素， 参与临床试验和其他监管科学研究的代表性不足的人群 有2个社区组织：社区药房和信仰组织;目标2：开展和评价卫生公平 模拟临床试验和其他健康公平监管科学研究的入组，以测试 CBO环境中的工作流程，如临床试验和其他研究的入组、保留和传播地点 监管科学研究;目标3：评估并优先考虑以行动为导向的健康公平活动， CBO解决健康公平相关障碍和促进因素并增加临床试验入组的能力 和其他监管科学研究的代表性不足的人群。