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

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.