Utilizing a Lupus Clinical Trials Network to Advance Diversity and Representation in Clinical Trials: Perspectives, Preferences, and Unmet Needs of Patients, Providers, and Stakeholder Agencies

标题：利用狼疮临床试验网络推进临床试验的多样性和代表性： 患者、提供者和利益相关者机构的观点、偏好和未满足的需求 项目摘要 尽管在少数种族和民族中系统性红斑狼疮（SLE）的患病率较高， 受疾病影响的患者与狼疮临床试验中的患者之间存在差距。推进 招募代表性不足的人群对于确保该过程的安全性、有效性和公平性至关重要， 临床试验的产品导致开发新的狼疮疗法。然而，很少有研究 探讨了患者和其他关键利益相关者群体的独特观点，以确定促进者， 增加不同种族和族裔参与者代表性的切实解决办法，特别是在 狼疮临床试验该提案的目标是通过以下方式促进狼疮临床试验的公平性： 新的数据来源，以推进临床试验中代表性不足人群入组的证据，B） 提高对主要利益攸关方不同声音的理解，以确定障碍、促进因素， 切实可行的解决方案，以及c）制定以患者为中心的临床试验沟通策略和技能培训 临床医生改善狼疮临床试验参与者的多样性。我们将利用知识翻译 框架和混合方法，以确定、交流、综合和传播见解 以促进狼疮临床试验的多样性。我们将利用与最大的狼疮临床试验的伙伴关系， 在北美的网络，狼疮临床研究者网络（LuCIN），并与关键合作 利益相关者群体，以实现拟议目标。该项目的第一个具体目标是利用 现有的数据，以建立一个多变量数据集的参与者和网站的水平特征内狼疮 临床试验网络。第二个具体目标是描述观点、偏好和未满足的需求 不同的利益相关者群体，以改善代表性不足的群体参与第二和第三阶段狼疮 临床试验讨论将探讨利益相关者对障碍、促进因素和有形资产的看法。 在个人，人际，组织和系统层面的解决方案，以提高狼疮的代表性 临床试验;并评估利益相关者对以患者为中心的实用沟通工具包的偏好， 临床医生将临床试验讨论纳入临床护理。第三个目标是综合实用 方法和资源，以提高狼疮临床试验的多样性和代表性。利用来自 目标2，我们将提交一份白色文件摘要，概述实际解决方案的框架，以改进 狼疮临床试验中的代表。下一步，我们将开发一个在线工具包模型， 临床医生，结合理论为基础的和循证的方法，以提高以病人为中心的 临床试验通信。我们将召开最后一次公开圆桌会议，让利益相关者审查 白色文件调查结果和在线工具包模型。我们渴望制定和传播一个有形的 改善狼疮临床试验多样性的知情者解决方案;并确定改进 交流技能工具包模型，在今后的研究中由不同的利益攸关方提供信息。

Title: Utilizing a Lupus Clinical Trials Network to Advance Diversity and Representation in Clinical Trials: Perspectives, Preferences, and Unmet Needs of Patients, Providers, and Stakeholder Agencies Project Abstract Despite greater prevalence of systemic lupus erythematosus (SLE) among racial and ethnic minorities, marked gaps exist between patients affected by the disease and those represented in lupus clinical trials. Advancing enrollment of underrepresented populations is critical to ensure safety, efficacy, and equity in the process and products from clinical trials leading to the development of novel lupus therapeutics. However, few studies have explored the unique perspectives of patients and other key stakeholder groups to identify facilitators and tangible solutions to increase representation of diverse racial and ethnic participants, particularly in the context of lupus clinical trials. The goal of this proposal is to advance equity in lupus clinical trials by: a) leveraging novel data sources to advance evidence for enrollment of underrepresented populations in clinical trials, b) increasing understanding of diverse voices of key stakeholders in order to identify barriers, facilitators, and tangible solutions, and c) developing patient-centered clinical trial communication strategies and skills training for clinicians to improve participant diversity in lupus clinical trials. We will utilize a knowledge translation framework and mixed-methods approach in order to identify, exchange, synthesize, and disseminate insights to advance diversity in lupus clinical trials. We will leverage partnerships with the largest lupus clinical trials network in North America, the Lupus Clinical Investigators Network (LuCIN), and collaboration with key stakeholder groups to accomplish the proposed aims. The first specific aim of this project is to leverage existing data to establish a multivariable dataset of participant- and site-level characteristics within the lupus clinical trials network. The second specific aim is to describe the perspectives, preferences, and unmet needs of diverse stakeholder groups to improve participation of underrepresented groups in Phase II and III lupus clinical trials. Discussions will explore stakeholders’ perspectives on the barriers, facilitators, and tangible solutions at the individual, interpersonal, organizational, and systems-level to improve representation in lupus clinical trials; and assess stakeholders’ preferences for a practical patient-centered communication toolkit for clinicians to integrate clinical trial discussions into clinical care. The third aim is to synthesize practical approaches and resources to improve diversity and representation in lupus clinical trials. Using findings from Aim 2, we will present a white paper summary outlining a framework of practical solutions to improve representation in lupus clinical trials. As a tangible next step, we will develop a mockup of an online toolkit for clinicians that incorporates theoretically-based and evidence-informed approaches to improve patient-centered clinical trials communication. We will convene a final public roundtable meeting for stakeholders to vet the white paper findings and online toolkit mockup. We aspire to develop and disseminate a framework of tangible stakeholder-informed solutions to improve lupus clinical trial diversity; and identify steps to refine the communications skills toolkit mockup informed by diverse stakeholders in future research.