Advancing equity through the Alliance for Representative Trials (ARC) program to diversify and bring industry-sponsored trials to communities of color and underrepresented communities

通过代表性试验联盟 (ARC) 计划促进公平，使有色人种社区和代表性不足的社区多样化并引入行业赞助的试验

• 批准号: 10638169
• 负责人: Christina Edwards
• 金额: $ 49.64万
• 依托单位: NATIONAL MINORITY QUALITY FORUM, INC.
• 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/10638169
• 关键词: Advancing; equity; through; Alliance; Representative

PROJECT SUMMARY / ABSTRACT Background. Representation of racial and ethnic minorities in clinical trials is needed to ensure that regulated medical products reflect and treat the intended treatment population and produce generalizable results; however, limited knowledge exists on the effectiveness of actionable solutions to improve diversity in clinical trials as well as cost-efficient ways to increase community practitioner and clinician capacity to participate in clinical research. Goal. The primary project goal is to demonstrate that minority-serving community clinicians can be trained and certified to be principal investigators (PIs) for randomized clinical trials and real world studies as well as upgrade their practices as trial sites. Methods. To achieve the the goal, the Alliance for Representative Clinical Trials (ARC), a multi-sponsor public/private program organized to diversify and bring clinical trials to communities of color and other communities that have been underrepresented in clinical trials, will be scaled up by increasing the number of minority-serving clinicians who have been trained to be principal investigators (PI) to lead drug and device randomized clinical trials. We propose to develop the knowledge, products, and processes needed to expand the ARC initiative. Our research question is: Will ARC be successfully adopted, implemented, and sustained through existing channels using this implementation process? A case study will be implemented to evaluate the effectiveness of the ARC initiative on improving minority-serving practitioners' and clinicians' capacity to participate in clinical research in a 12-month period. Objectives. The proposed project will train and certify community clinicians to be PIs, place study coordinators in their practice, and upgrade their logistical systems so they can support clinical trials. Once certified as PIs, these practices will be enrolled in the Clinical Investigative Site Network (CISN) as a clinical trial site. Certified practices will immediately be offered the opportunity to be an investigative site for several privately funded studies that CISN is managing, and CISN will continuously reach out to public/private trial sponsors to bring other study opportunities to them. Dissemination and Innovation. A project evaluation will be conducted to ensure that the tools and interventions used are effective, responsive, and equipped for widespread dissemination when the funding ends. To prepare for dissemination, we will consult with the Association of Black Cardiologists to refine ARC processes and practices and utilize an Evaluation Board to evaluate and guide project activities. Project results are likely to impact the field by improving technical abilities and clinical practice to: recruit and train minority-serving community clinicians to implement clinical trials; create a sustainable solution to improving the recruitment and retention of diverse populations in clinical trials; and create an infrastructure for community clinics to participate in clinical trials, increasing the accessibility of trials to underrepresented groups. The proposed project is innovative because it systematically examines the process of expanding the ARC initiative, a potentially sustainable solution to improving diversity in clinical trials.

项目摘要/摘要 背景资料。需要在临床试验中代表种族和少数民族，以确保受监管的 医疗产品反映和治疗预期治疗人群，并产生可推广的结果； 然而，关于改善临床多样性的可操作解决方案的有效性方面的知识有限。 试验以及提高社区医生和临床医生参与能力的经济高效的方式 临床研究。进球了。该项目的主要目标是证明为少数族裔服务的社区临床医生 可以被培训和认证为随机临床试验和现实世界的首席研究员(PI) 研究以及升级他们作为试验点的做法。方法：研究方法。为了实现这一目标，联盟 代表性临床试验(ARC)，这是一个多赞助商的公共/私人计划，旨在实现多样化和 对有色人种社区和其他在临床试验中代表性不足的社区进行临床试验， 将通过增加少数族裔服务的临床医生的数量来扩大规模，这些医生已经被培训为主任医师 研究人员(PI)领导药物和设备的随机临床试验。我们建议发展知识， 扩大ARC倡议所需的产品和流程。我们的研究问题是：ARC会成为 使用此实施通过现有渠道成功采用、实施和维持 流程呢？将实施一项案例研究，以评估ARC倡议在改善 少数群体服务从业者和临床医生在12个月内参与临床研究的能力。 目标。拟议的项目将培训和认证社区临床医生成为PIs，地方研究协调员 在实践中，并升级他们的后勤系统，以便他们能够支持临床试验。一旦被认证为PI， 这些实践将作为临床试验站点被纳入临床研究站点网络(CSN)。经认证 Practice将立即有机会成为几个私人资助的调查网站 CSN正在管理的研究，CSN将继续接触公共/私人试验赞助商，以带来 给他们其他的学习机会。传播创新。将进行项目评估，以 确保所使用的工具和干预措施是有效的、反应迅速的，并准备好广泛传播 在资金结束时进行传播。为了做好传播的准备，我们将与 黑人心脏病专家改进ARC流程和实践，并利用评估委员会评估和 指导项目活动。项目成果可能会通过提高技术能力和临床应用来影响该领域 实践：招聘和培训为少数族裔服务的社区临床医生，以实施临床试验；创建 可持续解决办法，以改善临床试验中不同人群的招募和留住；以及 创建社区诊所参与临床试验的基础设施，增加试验的可及性 对未被充分代表的群体。拟议的项目具有创新性，因为它系统地检查了 扩大ARC倡议的进程，这是一个潜在的可持续的解决方案，以提高临床试验的多样性。