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

最近的一项分析显示，近五分之一的临床试验要么因参与者失败而终止，要么完成 预计招生人数的85%。这些招聘挑战最终会降低 医学的进步惠及普通民众。招聘策略应放在礼仪的首位 发展讨论；然而，临床研究团队通常只在粗略之后才讨论招募战略 患者评估表明是可行的，在研究方案制定完成、得到IRB批准并准备就绪后 来招收第一个病人。不足为奇的是，研究协调员随后发现自己与 招募符合狭义纳入标准的患者，并通过众多 (有时是繁重的)学习访问。招聘创新中心计划具有真正转型的潜力 研究招募和招生情况。我们提出了一套创新、集成的解决方案来 招聘和注册挑战，适应真正的道德、法规、法律、实践和技术 调查人员面临的制约因素。这些将通过改进的临床试验教育提供， 在CTSA中心(i-CERCH)的招聘和注册。将为调查人员提供解决方案， 招募阶段：基础招募教育、研究队列确定和评估、社区 参与、预筛选、知情同意、登记和保留监测以及研究退还 结果。我们的解决方案的基础将是一个全国性、疾病中立和信息学支持的系统，该系统支持 报名参加个人试验。我们将利用已在使用的现有征聘和数据工具及资源 由我们的团队和其他人(例如ResearchMatch8、RecordCounter、REDCap9、TrialFinder和SubjectLocater) 组建一个复杂的基于信息学的招聘基础设施。信息学基础设施将配对 通过招聘专家提供的特定于学习的支持、可定制的招聘材料以及 有意义的社区参与。I-CERCH将由保罗·哈里斯博士领导，他将担任PI负责人 信息学发展，以及康苏埃洛·H·威尔金斯，医学博士，MSCI，将担任社区和利益相关者的PI 订婚。与其他4个CTSA建立伙伴关系有助于广泛了解CTSA的需求和关键专业知识。 该方案的具体目标如下：1)为 创建、存储和共享招聘教育、计划和最佳实践；2)通过以下方式促进注册 制定和传播新的技术和程序方法，以支持研究人员的招聘 参与者；3)通过患者教育提高全民科研意识，促进参与者 使用新的面向患者的在线工具确定研究；以及4)对以下方法进行严格的研究 提高招聘效力/效率，并根据这些数据进行修改。

A recent analysis shows that nearly 1 in 5 clinical trials either terminated for failed participant accrual, or completed with <85% of the expected enrollment. These recruitment challenges ultimately reduce the speed with which advances in medicine reach the general population. Recruitment strategies should at the forefront of protocol development discussions; however, clinical research teams often discuss recruitment strategies only after crude patient estimates suggest feasibility, and after a study protocol has been written, approved by an IRB, and is ready to enroll the first patient. Not surprisingly, study coordinators then find themselves with the difficult task of recruiting patients who meet narrow inclusion criteria, and retaining participants through numerous (sometimes onerous) study visits. The Recruitment Innovation Center program has the potential to truly transform the research recruitment and enrollment landscape. We propose a set of innovative, integrated solutions to recruitment and enrollment challenges that accommodate real ethical, regulatory, legal, practical, and technical constraints faced by investigators. These will be available through the Improving Clinical Trial Education, Recruitment and Enrollment at CTSA Hubs (I-CERCH) Center. Solutions will be available to investigators for every stage of recruitment: foundational recruitment education, study cohort identification and estimation, community engagement, pre-screening, informed consent, enrollment and retention monitoring, and returning of research results. Underlying our solutions will be a national, disease-neutral and informatics supported system that supports enrollment for individual trials. We will build upon existing recruitment and data tools and resources already in use by our team and others (e.g. ResearchMatch8, RecordCounter, REDCap9,TrialFinder, and SubjectLocater) to assemble a sophisticated informatics-based recruitment infrastructure. The informatics infrastructure will be paired with study-specific support provided by recruitment specialists, customizable recruitment materials, and meaningful community engagement. I-CERCH will be led by Paul Harris, PhD, who will serve as PI responsible informatics development, and Consuelo H. Wilkins, MD, MSCI, who will serve as PI of community and stakeholder engagement. Partnerships with 4 other CTSAs provide broad understanding of CTSA needs and key expertise. The specific aims of the program are as follows: 1) Provide a national home and collaborative `storefront' for the creation, storing, and sharing of recruitment education, programs, and best practices; 2) Catalyze enrollment by developing and disseminating novel technical and procedural approaches to support researchers in recruiting participants; 3) Enhance national awareness of research through patient education, and facilitate participant identification of studies with novel online patient facing tools; and 4) Conduct rigorous studies on methods to enhance recruitment efficacy/efficiency and make modifications based on these data.