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

利用狼疮临床试验网络促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

• 批准号: 10639164
• 负责人: Saira Z Sheikh
• 金额: $ 50万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/10639164
• 关键词: Utilizing; Lupus; Clinical; Trials; Network

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.

标题：利用狼疮临床试验网络促进临床试验的多样性和代表性： 患者、提供者和利益相关机构的观点、偏好和未满足的需求 项目摘要 尽管系统性红斑狼疮(SLE)在种族和少数民族中的患病率更高，但显著 受这种疾病影响的患者和狼疮临床试验中的代表之间存在差距。前进 招收代表性不足的人群对于确保这一过程中的安全性、有效性和公平性至关重要 来自临床试验的产品，导致了新型狼疮治疗药物的开发。然而，很少有研究表明 探索患者和其他关键利益相关者群体的独特视角，以确定促进者和 切实解决办法，以增加不同种族和族裔参与者的代表性，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：a)利用 新的数据来源，以促进在临床试验中招募代表性不足的人群的证据，b) 加深对关键利益相关方不同声音的理解，以确定障碍、促进者和 切实的解决方案，以及c)开发以患者为中心的临床试验沟通策略和技能培训 为临床医生在狼疮临床试验中提高参与者多样性提供参考。我们将利用知识翻译 框架和混合方法方法，以确定、交流、综合和传播见解 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合作伙伴关系 北美网络、狼疮临床研究人员网络(Lucin)以及与KEY的合作 利益相关者团体以实现拟议的目标。这个项目的第一个具体目标是利用 现有数据以在狼疮内建立参与者和站点级特征的多变量数据集 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 促进不同利益攸关方群体参与狼疮第二阶段和第三阶段的工作 临床试验。讨论将探讨利益相关者对障碍、促进者和有形 在个人、人际、组织和系统级别的解决方案，以提高狼疮的代表性 临床试验；并评估利益相关者对实用的以患者为中心的通信工具包的偏好 临床医生将临床试验讨论整合到临床护理中。第三个目标是综合实用 改善狼疮临床试验多样性和代表性的方法和资源。使用以下项目的调查结果 目标2，我们将提交白皮书摘要，概述实际解决方案的框架，以改进 狼疮临床试验中的代表性。作为具体的下一步，我们将为以下内容开发一个在线工具包的模型 临床医生结合了以理论为基础和以证据为基础的方法，以改善以患者为中心 临床试验交流。我们将召开最后一次公开圆桌会议，让利益相关者审查 白皮书调查结果和在线工具包模型。我们渴望开发和传播一个有形的 利益相关者知情的解决方案，以改善狼疮临床试验的多样性；并确定改进 在未来的研究中，由不同的利益相关者提供信息的沟通技能工具包模型。