背景:电子健康记录(EHRs)是一种具有成本效益的方法,可以为临床试验研究提供必要的基础。在现实世界的临床环境中使用EHR的能力允许在这些环境中对新兴的成人HIV人群进行务实的干预研究;然而,与在多中心临床试验中使用EHR数据相关的监管成分提出了独特的挑战,研究人员可能发现自己没有准备好应对这些挑战,这可能会导致研究实施的延误,并对研究时间表产生不利影响,并有不遵守既定指南的风险。
目的:作为针对HIV/AIDS干预方案162b(ATN162b)的大型青少年试验网络(ATN)研究的一部分,该研究评估了包括HIV治疗和暴露前预防服务在内的干预措施的临床结果,以改善新兴成人HIV人群的保留率。本研究的目的是强调在实施使用EHR的多中心务实试验过程中的监管过程和挑战,以帮助未来的研究人员在通常耗时的监管过程中进行类似的研究,并确保遵守研究时间表以及遵守机构和申办者指南.
方法:八个研究中心从事研究活动,作为ATN的一部分,从参与者招募场地中选择了4个地点,参与干预和数据提取活动的人,另有4个站点参与了数据管理和分析.ATN162b协议团队与现场人员合作,建立了必要的监管基础设施,以收集EHR数据,以评估在护理和病毒抑制中的保留率。以及干预部分的辅助数据,以评估移动健康干预的可行性和可接受性。发展这一基础设施的方法包括针对具体地点的培训活动以及制定机构依赖和数据使用协议。
结果:由于特定地点活动的差异,以及相关的监管影响,研究小组采用分阶段方法,数据提取点作为第1阶段,干预点作为第2阶段.这种分阶段的方法旨在解决所有参与站点的独特监管需求,以确保所有站点都正确登载,并且所有监管组件都已到位。在所有网站上,4个数据提取和干预站点的监管过程历时6个月,和长达10个月的数据管理和分析网站。
结论:使用EHR数据参与多中心临床试验研究的过程是一个多步骤,需要从提案阶段开始进行适当的高级计划,以充分实施必要的培训和基础设施。规划,培训,了解监管的各个方面,包括数据使用协议的必要性,信赖协议,外部机构审查委员会审查,以及与临床站点的接触,是确保成功实施和坚持务实审判时间表和结果的首要考虑因素。
BACKGROUND: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the
regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.
OBJECTIVE: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines.
METHODS: Eight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements.
RESULTS: Due to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique
regulatory needs of all participating sites to ensure that all sites were properly onboarded and all
regulatory components were in place. Across all sites, the
regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites.
CONCLUSIONS: The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various
regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.