Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Contemp Clin Trials. 2023 Mar;126:107110. doi: 10.1016/j.cct.2023.107110. Epub 2023 Feb 3.
Children have historically been underrepresented in randomized controlled trials and multi-center studies. This is particularly true for children who reside in rural and underserved areas. Conducting multi-center trials in rural areas presents unique informatics challenges. These challenges call for increased attention towards informatics infrastructure and the need for development and application of sound informatics approaches to the collection, processing, and management of data for clinical studies. By modifying existing local infrastructure and utilizing open source tools, we have been able to successfully deploy a multi-site data coordinating and operations center. We report our implementation decisions for data collection and management for the IDeA States Pediatric Clinical Trial Network (ISPCTN) based on the functionality needed for the ISPCTN, our synthesis of the extant literature in data collection and management methodology, and Good Clinical Data Management Practices.
儿童在随机对照试验和多中心研究中历来代表性不足。对于居住在农村和服务不足地区的儿童来说，情况尤其如此。在农村地区进行多中心试验带来了独特的信息学挑战。这些挑战需要更加关注信息学基础设施，以及开发和应用健全的信息学方法来收集、处理和管理临床研究数据的必要性。通过修改现有的本地基础设施并利用开源工具，我们已经能够成功部署一个多站点数据协调和运营中心。我们根据 ISPCTN 所需的功能、我们对数据收集和管理方法的现有文献的综合以及良好的临床数据管理实践，报告了我们为 IDeA 州儿科临床试验网络（ISPCTN）的数据收集和管理所做的实施决策。
