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: 9114803
• 负责人: Paul A. Harris
• 金额: $ 298.03万
• 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/9114803
• 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; General Population; Goals; Home environment; Individual; Informatics; Informed Consent; Institutional Review Boards; Judgment; Legal; Letters; Medicine; Methods; Modification; Monitor; Names; Participant; Patient Education; Patients; Persons; Protocols documentation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Resources; Specialist; Speed; Staging; Support System; Uncertainty; Visit; Writing; base; experience; improved; inclusion criteria; informatics infrastructure; innovation; learning progression; meetings; novel; patient population; programs; 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，要么以低于预期入组人数的 85% 完成，这些招募挑战最终降低了医学进步的速度。招募策略应放在开发讨论的最前沿；然而，临床研究团队通常只有在粗略的患者估计表明概率、研究方案已编写、经 IRB 批准并准备好招募后才讨论招募策略。第一个病人。毫不奇怪，研究协调员发现自己面临着招募符合狭窄纳入标准的患者并通过大量（有时是繁重的）研究访问留住参与者的艰巨任务。招募创新中心计划有可能真正改变研究招募和招生格局。我们针对招募和注册挑战提出了一套创新的综合解决方案，以适应研究者面临的真正的道德、监管、法律、实践和技术限制，这些解决方案将通过改进 CTSA 中心的临床试验教育、招募和注册来实现。 (I-CERCH) 中心。将为研究人员提供招募各个阶段的解决方案：基础招募教育、研究队列识别和评估、社区参与、预筛选、知情同意、注册和保留监控以及研究结果返回。我们的解决方案的基础将是一个国家级、疾病中立和信息学支持的系统，该系统支持个体试验的注册。我们将利用我们的团队和其他人已经使用的现有招募和数据工具和资源（例如 ResearchMatch8、Record Counter、 REDCap9、试验查找器和主题定位器）来组装复杂的基于信息学的招募基础设施。信息学基础设施将与特定研究配对。 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将由 Paul Harris 博士（负责信息学开发）和 Consuelo H. Wilkins（医学博士、MSCI）领导。社区和利益相关者参与的 PI 与其他 4 个 CTSA 的合作提供了对 CTSA 需求和关键专业知识的广泛了解。该计划的具体目标如下： 1) 为社区提供一个全国性的主页和协作“店面”。创建、存储和共享招募教育、计划和最佳实践； 2) 通过开发和传播新的技术和程序方法来支持研究人员招募参与者，从而促进招募； 3) 通过患者教育提高国家对研究的认识，并促进参与者使用面向患者的新型在线工具识别研究；以及 4) 对提高招募功效/效率的方法进行严格研究，并根据这些数据进行修改。