Khaos Research, ITIS Software, Universidad de Málaga, Arquitecto Francisco Peñalosa 18, Málaga, 29071, Spain.
Khaos Research, ITIS Software, Universidad de Málaga, Arquitecto Francisco Peñalosa 18, Málaga, 29071, Spain; Biomedical Research Institute of Málaga (IBIMA), Universidad de Málaga, Málaga, Spain; Departamento de Lenguajes y Ciencias de la Computación, Universidad de Málaga, Málaga, Spain.
Comput Methods Programs Biomed. 2021 Nov;212:106496. doi: 10.1016/j.cmpb.2021.106496. Epub 2021 Oct 25.
In the last decade, clinical trial management systems have become an essential support tool for data management and analysis in clinical research. However, these clinical tools have design limitations, since they are currently not able to cover the needs of adaptation to the continuous changes in the practice of the trials due to the heterogeneous and dynamic nature of the clinical research data. These systems are usually proprietary solutions provided by vendors for specific tasks. In this work, we propose FIMED, a software solution for the flexible management of clinical data from multiple trials, moving towards personalized medicine, which can contribute positively by improving clinical researchers quality and ease in clinical trials.
This tool allows a dynamic and incremental design of patients' profiles in the context of clinical trials, providing a flexible user interface that hides the complexity of using databases. Clinical researchers will be able to define personalized data schemas according to their needs and clinical study specifications. Thus, FIMED allows the incorporation of separate clinical data analysis from multiple trials.
The efficiency of the software has been demonstrated by a real-world use case for a clinical assay in Melanoma disease, which has been indeed anonymized to provide a user demonstration. FIMED currently provides three data analysis and visualization components, guaranteeing a clinical exploration for gene expression data: heatmap visualization, clusterheatmap visualization, as well as gene regulatory network inference and visualization. An instance of this tool is freely available on the web at https://khaos.uma.es/fimed. It can be accessed with a demo user account, "researcher", using the password "demo".
This paper shows FIMED as a flexible and user-friendly way of managing multidimensional clinical research data. Hence, without loss of generality, FIMED is flexible enough to be used in the context of any other disease where clinical data and assays are involved.
在过去的十年中，临床试验管理系统已成为数据管理和分析临床研究的重要支持工具。然而，这些临床工具存在设计上的局限性，因为它们目前无法满足因临床研究数据的异质性和动态性质而导致的试验实践不断变化的适应需求。这些系统通常是供应商为特定任务提供的专有解决方案。在这项工作中，我们提出了 FIMED，这是一种用于管理来自多个试验的临床数据的软件解决方案，旨在向个性化医疗发展，它可以通过提高临床研究人员的质量和临床试验的便利性，产生积极影响。
该工具允许在临床试验背景下动态且增量地设计患者档案，提供一个灵活的用户界面，隐藏使用数据库的复杂性。临床研究人员将能够根据他们的需求和临床研究规范定义个性化的数据模式。因此，FIMED 允许合并来自多个试验的单独临床数据分析。
通过对黑色素瘤疾病的临床检测的实际用例证明了该软件的效率，该用例实际上已被匿名化以提供用户演示。FIMED 当前提供三个数据分析和可视化组件，可确保对基因表达数据进行临床探索：热图可视化、聚类热图可视化，以及基因调控网络推断和可视化。该工具的实例可在 https://khaos.uma.es/fimed 上免费访问。可以使用演示用户帐户“researcher”访问，密码为“demo”。
本文展示了 FIMED 作为一种灵活且用户友好的管理多维临床研究数据的方法。因此，FIMED 具有足够的灵活性，可以在涉及临床数据和检测的任何其他疾病的背景下使用。
