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: 10158963
• 负责人: Paul A. Harris
• 金额: $ 140.39万
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158963
• 关键词: Address; Anecdotes; Antiviral Agents; Awareness; Benefits and Risks; COVID-19; COVID-19 pandemic; Caring; Clinical Research; Clinical Trials; Clinical trial protocol document; Cohort Studies; Communication; Communities; Data; Data Reporting; Development; Disease; Doctor of Philosophy; Education; Emergency Situation; Enrollment; Ethics; Evaluation; Feedback; Foundations; Funding; General Population; Home environment; Human; In Vitro; Individual; Informatics; Informed Consent; Infrastructure; Institution; Institutional Review Boards; Investigation; Language; Legal; Measures; Medicine; Methods; Misinformation; Modification; Monitor; Movement; Participant; Patient Education; Patient Recruitments; Patients; Peer Review; Population; Protocols documentation; Publishing; Reporting; Research; Research Infrastructure; Research Personnel; Retrospective Studies; Risk; Series; Services; Specialist; Speed; Support System; Supportive care; Testing; Therapeutic; Time; TimeLine; Trust; Underrepresented Minority; Update; Visit; Visualization; base; data resource; data tools; ethnic minority population; evidence base; human data; improved; inclusion criteria; informatics infrastructure; innovation; novel; open label; pandemic disease; participant safety; patient population; programs; protocol development; racial minority; recruit; research study; response; risk prediction model; screening; tool; web site

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.

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应计失败而终止，要么完成 <预期入学率的 85%。这些招聘挑战最终会降低招聘速度 医学的进步惠及普通大众。招聘策略应处于协议的最前沿 发展讨论；然而，临床研究团队通常只在粗略的研究之后讨论招募策略 患者估计表明可行性，并且在研究方案编写完毕、经 IRB 批准并准备就绪后 登记第一位患者。毫不奇怪，研究协调员随后发现自己与 招募符合狭窄纳入标准的患者并通过大量的研究留住参与者是一项艰巨的任务 （有时是繁重的）考察访问。招聘创新中心计划具有真正变革的潜力 研究招募和招生情况。我们提出一套创新的综合解决方案 适应真正的道德、监管、法律、实践和技术的招聘和入学挑战 调查人员面临的限制。这些将通过改善临床试验教育提供， CTSA Hubs (I-CERCH) 中心的招募和注册。研究人员将为每个问题提供解决方案 招募阶段：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返回 结果。我们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 参加个人试验。我们将利用现有的招聘和数据工具以及已使用的资源 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 由招聘专家提供针对研究的支持、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 负责人 信息学开发，Consuelo H. Wilkins（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 的合作伙伴关系提供了对 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 创建、存储和共享招聘教育、计划和最佳实践； 2) 促进注册 开发和传播新颖的技术和程序方法以支持研究人员招募 参与者； 3）通过患者教育提高国民对研究的认识，并促进参与者 使用新颖的在线患者面对工具识别研究； 4) 对方法进行严格的研究 提高招聘效果/效率并根据这些数据进行修改。