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

改善 CTSA 中心的临床试验教育、招募和注册 (I-CERCH)

• 批准号: 9353931
• 负责人: Paul A. Harris
• 金额: $ 74.98万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9353931
• 关键词: Academic Medical Centers; Awareness; Clinical Research; Clinical Trials; Cohort Studies; Communities; Consent Forms; Data; Development; Disease; Doctor of Philosophy; Education; Electronic Health Record; Enrollment; Ethics; Failure; Foundations; General Population; Goals; Home environment; Individual; Informatics; Informed Consent; Institutional Review Boards; Judgment; Legal; Letters; Medicine; Methods; Modification; Monitor; Names; Participant; Patient Education; Patient Recruitments; Patients; Persons; Protocols documentation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Resources; Specialist; Speed; Support System; Uncertainty; Visit; base; experience; improved; inclusion criteria; informatics infrastructure; innovation; learning progression; multidisciplinary; novel; patient population; programs; prospective; protocol development; public health relevance; screening; tool

 DESCRIPTION (provided by applicant): 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 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 a 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, Record Counter, REDCap9, Trial Finder, and Subject Locater) 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.

 描述（由申请人提供）：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招募失败而终止，要么以预期招募人数的85%完成。这些招募方面的挑战最终降低了医学进步普及到普通民众的速度。招募策略应该在开发讨论的最前沿;然而，临床研究团队通常只在粗略的患者估计表明可行性之后，以及在研究方案已经编写，获得IRB批准并准备招募第一名患者之后，才讨论招募策略。毫不奇怪，研究协调员随后发现自己面临着招募符合狭窄入选标准的患者的艰巨任务，并通过多次（有时是繁重的）研究访视留住参与者。招聘创新中心计划有可能真正改变研究招聘和招生格局。我们提出了一套创新的、综合的解决方案来应对招募和入组的挑战，这些挑战适应了研究者面临的真实的伦理、监管、法律的、实践和技术限制。这些将通过CTSA Hubs（I-CERCH）中心的改善临床试验教育，招募和入组提供。研究者将在招募的每个阶段获得解决方案：基础招募教育、研究队列识别和估计、社区参与、预筛选、知情同意、招募和保留监测以及研究结果返回。我们的解决方案将是一个全国性的、疾病中立的、信息支持的系统，支持个体试验的招募。我们将在现有的招募和数据工具以及我们的团队和其他人已经使用的资源（例如ResearchMatch 8，Record Counter，REDCap 9，Trial Locator和Subject Locater）的基础上构建一个复杂的基于信息的招募基础设施。信息学基础设施将与研究特定的 招聘专家提供的支持、可定制的招聘材料以及有意义的社区参与。I-CERCH将由Paul Harris博士领导，他将担任PI负责信息学开发，Consuelo H。威尔金斯，医学博士，MSCI，谁将担任PI的社区和利益相关者的参与。与其他4个CTSA的伙伴关系提供了对CTSA需求和关键专业知识的广泛了解。该方案的具体目标如下：（1）提供一个全国性的主页和协作“店面”，用于创建、储存和分享招募教育、方案和最佳做法;（2）通过开发和传播新的技术和程序方法来促进招募，以支持研究人员招募参与者; 3）通过患者教育提高国家对研究的认识，并通过新颖的在线患者面对工具促进参与者识别研究; 4）对提高招聘效率的方法进行严格的研究，并根据这些数据进行修改。