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.

项目概要/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 通过创新应用扩大规模，通过多样化的社区招聘网站实现 该提案建立在大学的基础上。 马里兰州巴尔的摩 (UMB) 患者计划十年来推进健康公平研究和科学 与已建立的社区组织 (CBO) 合作的参与度 (1) 沃尔格林 (Walgreens)，全国第二大社区药房网络和 (2) 黎巴嫩山浸信会教堂 (Mt. Lebanon Baptist Church) (MLBC) 是一家非裔美国教会，一直是患者计划的长期合作伙伴。 Mullins 博士和患者计划推进了参与科学，该科学建立在 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，例如 患者、社区提供者、社区健康倡导者、学习健康系统管理员，以及 让其他利益相关者参与科学调查是更多元化的利益相关者团队的参与。 提议作为整合多方利益相关者观点的一种手段，通过协作和协同可以 在利用社区组织全面推进多元化举措之前，重要的是： 制作“概念验证”，以证明 CBO 有效识别、招募、推荐、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验证。 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 国会预算办公室地点。 拟议的模拟练习与 Mullins 博士基于证据的连续 10 步框架相一致 我们的模拟练习旨在评估患者和利益相关者是否以及如何参与。 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 为了实现这一总体目标，我们提出了以下三个目标： 目标 1：协作确定优先顺序。 健康模拟公平情景，以解决公平健康相关的障碍和促进因素 参与临床试验和其他合作监管科学研究的人群代表性不足 与 2 个社区组织合作：社区药房和信仰组织；目标 2：开展和评估健康公平性； 模拟公平临床试验和其他健康监管科学研究的招募，以测试可行性 CBO 设置中的工作流程作为临床试验和其他项目的登记、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卫生活动，以加强 CBO 解决与健康公平相关的障碍和促进因素并增加临床试验注册人数的能力 以及代表性不足的人群的其他监管科学研究。