Biopharmacy, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland.
Scientific IT Services, ETH Zürich, Zürich, Switzerland.
CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1578-1587. doi: 10.1002/psp4.12723. Epub 2021 Nov 2.
Clinical trials have been performed mainly in adults and accordingly the necessary information is lacking for pediatric patients, especially regarding dosage recommendation for approved drugs. This gap in information could be filled with results from pharmacokinetic (PK) modeling, based on data collected in daily clinical routine. In order to make this data accessible and usable for research, the Swiss Pharmacokinetics Clinical Data Warehouse (SwissPK ) project has been set up, including a clinical data warehouse (CDW) and the regulatory framework for data transfer and use within. Embedded into the secure BioMedIT network, the CDW can connect to various data providers and researchers in order to collaborate on the data securely. Due to its modularity, partially containerized deployment and open-source software, each of the components can be extended, modified, and re-used for similar projects that require integrated data management, data analysis, and web tools in a secure scientific data and information technology (IT) environment. Here, we describe a collaborative and interprofessional effort to implement the aforementioned infrastructure between several partners from medical health care and academia. Furthermore, we describe a real-world use case where blood samples from pediatric patients were analyzed for the presence of genetic polymorphisms and the results were aggregated and further analyzed together with the health-related patient data in the SwissPK .
临床试验主要在成年人中进行，因此缺乏儿科患者的必要信息，特别是关于已批准药物的剂量建议。这种信息差距可以通过基于日常临床实践中收集的数据进行药代动力学（PK）建模来填补。为了使这些数据可用于研究，已经建立了瑞士药代动力学临床数据仓库（SwissPK）项目，其中包括临床数据仓库（CDW）和用于数据传输和内部使用的监管框架。嵌入到安全的 BiomedIT 网络中，CDW 可以连接到各种数据提供者和研究人员，以便安全地合作处理数据。由于其模块化、部分容器化部署和开源软件，每个组件都可以扩展、修改和重新用于需要在安全的科学数据和信息技术（IT）环境中集成数据管理、数据分析和网络工具的类似项目。在这里，我们描述了一项合作和跨专业的努力，即在来自医疗保健和学术界的几个合作伙伴之间实施上述基础设施。此外，我们还描述了一个实际用例，其中对儿科患者的血液样本进行了分析，以确定是否存在遗传多态性，并将结果与 SwissPK 中的与健康相关的患者数据一起进行汇总和进一步分析。
