Real-World Accelerator to evolve the standard of Care and Engagement in clinical studies (RACE)

现实世界加速器旨在发展临床研究中的护理和参与标准 (RACE)

• 批准号: 10878229
• 负责人: Carla Rodriguez-Watson
• 金额: $ 37.5万
• 依托单位: REAGAN-UDALL FOUNDATION/FOOD/DRUG/ADMIN
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10878229
• 关键词: Real; World; Accelerator; evolve; standard

Incomplete and inconsistent capture of race and ethnicity data from real-world data (RWD) limits the full description of the distribution, safety, and effectiveness of FDA regulated products in the population. The issues involved with acquisition and treatment of race and ethnicity data touch many domains (e.g. health disparities, health IT, workforce training, standards and policy development) and require diverse viewpoints to share knowledge and perspectives to drive solutions. Moreover, leadership from both government and the private sector are essential to muster organizational commitment and prioritize resources to implement solutions to this multi-factorial puzzle. The status quo has been to think about the problem and solutions in silos and through a narrow lens. Our goal is to increase diversity in pre- and post-market studies (including those conducted via RWD). Our objective is to understand, align, and disseminate best practices to improve real-world reporting, collection, capture, protection, aggregation, integration, and interpretation of race and ethnicity data. RACE will bring together leadership from broad sectors in a series of roundtables to advance solutions to enhance the acquisition and treatment of race and ethnicity data from real-world settings for research purposes (Aim 1). Additionally, we will conduct a landscape assessment of best practices and a public poll to assess patients’ reactions to questions of race and ethnicity to inform the roundtable series. We will summarize best practices and crowd-source the most viable solutions; amplifying the findings in public- facing multi-media to reach broad audiences and stimulate further conversation and action. The significance of Aim 1 is in the opportunity for collective learning and community capacity building. In Aim 2, we will evaluate the impact of RACE to initiate a change in practice using a pre-post, qualitative design. Interviews in ~ 30 people will be recorded, transcribed, and coded; using a template analysis approach to analyze the data and develop domain-level memos to facilitate qualitative assignment of strength and valence for each domain. We will also create stakeholder-level memos to assess change on the group level. The significance of demonstrating that bringing leaders together in a dynamic forum motivates individual change is that this model may be applied to address additional questions. In Aim 3, we will map the most salient solutions to the barriers they address. We will provide the summary of the barrier-solution to RACE participants and request feedback on the perceived effort and value of implementing the proposed solutions. This summary output will serve as a novel, multi-dimensional tool to develop strategies for implementing perceived high-value solutions; the significance of which is in providing stakeholders with a tool to prioritize and implement solutions to improve the quality of race and ethnicity data in their own environment. In short, this work will advance the discussion about the collection and use of race/ethnicity data toward action by building community capacity among leadership and collaboratively developing tools to change practice.

从真实世界数据(RWD)捕获种族和族裔数据的不完整和不一致限制了完整 FDA监管产品在人群中的分布、安全性和有效性的说明。这个 与种族和族裔数据的获取和处理有关的问题涉及许多领域(例如健康 差距、卫生信息技术、劳动力培训、标准和政策制定)，并需要不同的观点来 分享知识和观点以推动解决方案。此外，来自政府和政府的领导层 私营部门对于凝聚组织承诺和优先执行资源至关重要 解决这个多因素的难题。现状是一直在思考问题和解决方案 筒仓和通过一个狭窄的镜头。我们的目标是增加上市前和上市后研究的多样性(包括 通过RWD进行的那些)。我们的目标是了解、调整和传播最佳实践，以改进 真实世界对种族和种族的报道、收集、捕获、保护、聚合、整合和解释 种族数据。RACE将在一系列圆桌会议上汇聚来自广泛行业的领导层，以推进 加强从现实世界环境中获取和处理种族和族裔数据的解决方案 研究目的(目标1)。此外，我们还将对最佳实践和 公共民意调查，以评估患者对种族和民族问题的反应，为圆桌会议系列提供信息。我们 将总结最佳实践并众包最可行的解决方案；在公众中放大调查结果- 面对多媒体，以接触到广泛的受众，并刺激进一步的谈话和行动。的重要意义。 目标1是集体学习和社区能力建设的机会。在目标2中，我们将评估 比赛的影响，在实践中发起变革，采用事前、事后、定性的设计。约30次面试 人们将被记录、转录和编码；使用模板分析方法来分析数据和 制定领域级别的备忘录，以便于对每个领域的强度和价位进行定性分配。我们 还将创建利益相关者级别的备忘录，以评估集团级别的变化。的重要意义。 证明了将领导人聚集在一个动态的论坛上会激励个人变革，这一模式 可以用来解决其他问题。在目标3中，我们将把最突出的解决方案映射到障碍 他们的地址。我们将向参赛者提供障碍解决方案的摘要，并要求反馈 关于实施提议的解决方案的感知努力和价值。此摘要输出将用作 新的多维工具，用于制定实施可感知的高价值解决方案的战略； 其意义在于为利益相关者提供了一种工具，以确定优先顺序并实施解决方案以改进 种族和民族数据在他们自己的环境中的质量。简而言之，这项工作将推进讨论 关于收集和使用种族/族裔数据，以便采取行动，在 领导力和协作开发工具以改变实践。