Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL Supplement

为应对国家阿片类药物公共卫生危机，美国国立卫生研究院推出了Hear(帮助 长期戒瘾)倡议，该倡议旨在加快研究，以改善治疗 治疗成瘾并加强疼痛管理。治愈疼痛管理的有效性 研究网络(ERN)是该倡议的关键组成部分，要想取得成功，这些ERN 试验将需要有效地招募参与者，并将辍学降至最低。确保治愈疼痛ERN 研究积累并保留评估小学和中学课程所需参与者的数量和多样性 二次成果，我们建议对招聘创新中心进行补充，以支持 开发强大的招聘基础设施，包括工具、资源和 需要创新战略，以主动解决招聘障碍，并迅速确定和 减少站点间新出现的路障。由保罗·哈里斯博士和康苏埃洛·H·威尔金斯领导， MD，MSCI，本附录将重点支持和纳入招聘和 在所有研究阶段(设计、规划、方案制定、启动、 实施和传播)，以准确评估招聘可行性，最大限度地减少 挑战，并优化招聘、留住和向所有参与者返还价值。我们会 利用招聘创新中心(RIC)的现有资源并利用 关于我们团队能力的重要主题领域，包括：1)以参与者为中心 识别疼痛患者不同需求和偏好的方法；2)多方面 将信息学工具与上下文数据源和系统相结合的方法(例如 电子健康记录)以指导全面的招聘战略；3)参与 患者、社区团体和临床医生在研究的所有阶段；以及4)应用现有的 和新的招聘方法和工具，以促进最佳做法的证据基础 招募这些人。本附录的首要目标是帮助提高效率 为治疗疼痛临床试验招募和保留不同样本的参与者。我们会 利用RIC的丰富专业知识和集中化基础设施，并与每个 三个试验创新中心(TICS)支持NIH的跨机构发展努力 国家阿片类药物危机的科学解决方案。

In response to the national opioid public health crisis, NIH has launched the HEAL (Helping to End Addiction Long-term) Initiative, which intends to speed research that will improve treatment for addiction and enhance pain management. The HEAL Pain Management Effectiveness Research Network (ERN) is a key component of the initiative and to be successful, these ERN trials will need to efficiently recruit participants and minimize dropouts. To ensure HEAL Pain ERN studies accrue and retain the number and diversity of participants required to assess primary and secondary outcomes, we propose a Supplement to the Recruitment Innovation Center to support the development of a robust recruitment infrastructure, complete with the tools, resources, and innovative strategies needed to proactively address recruitment barriers and rapidly identify and mitigate emerging roadblocks across sites. Led by Paul Harris, PhD and Consuelo H. Wilkins, MD, MSCI, this supplement will focus on supporting and incorporating recruitment and engagement expertise through all study stages (design, planning, protocol development, start-up, implementation, and dissemination) to accurately assess recruitment feasibility, minimize challenges, and optimize recruitment, retention, and return of value to all participants. We will leverage existing resources available in the Recruitment Innovation Center (RIC) and capitalize on important thematic areas of competency of our team that includes; 1) participant-centered approaches that recognize varying needs and preferences of individuals with pain; 2) multifaceted approaches that combine informatics tools and contextual data sources and systems (e.g. electronic health records) to guide comprehensive recruitment strategies; 3) engagement of patients, community groups and clinicians in all stages of the studies; and 4) application of existing and novel recruitment methods and tools to advance the evidence base for best practices in recruiting these populations. The overarching goal of this supplement is to aid in the efficient recruitment and retention of a diverse sample of participants for HEAL Pain clinical trials. We will leverage the vast expertise and centralized infrastructure of the RIC and collaborate with each of the three Trial Innovation Centers (TICs) to support NIH’s trans-agency efforts to develop scientific solutions to the national opioid crisis.