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

从真实世界数据（RWD）中获取的人种和种族数据不完整和不一致， 描述FDA监管产品在人群中的分布、安全性和有效性。的 涉及种族和族裔数据的获取和处理的问题涉及许多领域（如健康 差异，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， 分享知识和观点以推动解决方案。此外，政府和 私营部门对于调动组织承诺和确定资源优先次序， 解决这个多因素难题的方法目前的情况是， 筒仓和通过狭窄的透镜。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）。我们的目标是了解、调整和传播最佳实践， 真实世界的报告，收集，捕获，保护，聚合，整合和种族和 种族数据。RACE将在一系列圆桌会议上汇集来自广泛部门的领导， 解决方案，以加强从现实世界环境中获取和处理种族和族裔数据， 研究目的（Aim 1）。此外，我们将对最佳做法进行景观评估， 公众调查，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 将总结最佳做法，并将最可行的解决方案集中在众包中;在公共场合扩大调查结果， 面对多媒体，以达到广泛的受众，并激发进一步的对话和行动。的意义 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 种族竞争教育的影响，以启动在实践中的变化，使用前后，定性设计。面试~ 30 人将被记录，转录和编码;使用模板分析方法来分析数据， 开发领域级别的备忘录，以促进每个领域的强度和效价的定性分配。我们 还将创建负责人级别的备忘录，以评估集团级别的变化。的意义 这一模式表明，将领导者聚集在一个充满活力的论坛上， 可用于解决其他问题。在目标3中，我们将为障碍绘制最突出的解决方案 他们解决。我们将向RACE参与者提供障碍解决方案的摘要并要求反馈 实施拟议解决方案的预期努力和价值。此摘要输出将作为 一种新颖的多维工具，用于制定实施高价值解决方案的战略; 其重要性在于为利益攸关方提供了一种工具，用于确定解决方案的优先次序并实施这些解决方案， 种族和族裔数据的质量。简而言之，这项工作将推动讨论 关于收集和使用种族/族裔数据，以便通过建立社区能力， 领导力和协作开发工具来改变实践。

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.