Secure Web-Based Flow Cytometry in Clinical Use and Translational Research

描述（由申请人提供）：流式细胞术能够测量单个细胞的30个或更多参数，使其成为分析复杂细胞混合物的完美工具，例如来自各种疾病患者的外周血或肿瘤样本。新的分析方法使研究人员能够测量单个细胞内的信号通路，从而深入了解癌症和免疫疾病的病理。Cytobank是一个基于web的软件平台，用于管理、共享和分析流式细胞术数据，为最终用户提供直接从原始流式细胞术数据生成复杂数据可视化（如热图）的能力。目前，流式细胞仪数据的充分分析和传播需要多个软件平台，难以满足患者信息保护法规的严格要求。在本次授权中，我们将通过确保符合21 CFR Part 11和开发常用临床检测模板来扩展Cytobank的能力。这将使临床研究人员能够将尖端的流式细胞术分析转移到临床，因为他们将能够安全地与可以协助数据分析和统计解释的批准人员共享数据。该资助的目的是：1)为细胞库中的记录实施电子签名；2)为数据管理和分析的所有步骤创建审计跟踪；3)为临床免疫监测和癌症转化研究中的常规分析创建分析模板。使Cytobank符合临床要求的最终目标是，通过使研究成果更有效地转化为临床环境，主要是通过一个简单易用的数据管理和分析界面将临床医生和研究人员联系起来，从而促进全球健康。

DESCRIPTION (provided by applicant): The ability of flow cytometry to measure 30 or more parameters on individual cells makes it a perfect tool for analyzing complex mixtures of cells such as peripheral blood or tumor sample from patients with various diseases. New assays have enabled researchers to measure signaling pathways inside individual cells, providing insight into the pathology of cancers and immunological disorders. Cytobank is a web--‐based software platform for the management, sharing, and analysis of flow cytometry data, providing end users with the ability to generate complex data visualizations such as heatmaps directly from raw flow cytometry data. Currently, multiple software platforms are required for fully analyzing and disseminating data from flow cytometers, therefore making it difficult to comply with the strict requirements of patient information protection regulations. In this grant, we will extend the capabilities of Cytobank by ensuring compliance with 21 CFR Part 11 and developing templates for commonly performed clinical assays. This will allow clinical researchers to move cutting edge flow cytometry assays into the clinic, as they will be able to securely share data with approved individuals who can assist in data analysis and statistical interpretation. The Aims of the grant are to 1) implement an electronic signature for records in Cytobank, 2) create an audit trail for all steps of data management and analysis, and 3) create analysis templates for routine analyses in clinical immune monitoring and translational research in cancer. The ultimate goal of making Cytobank clinically compliant is to enhance global health by enabling more efficient translation of research findings into clinical settings, primarily by connecting clinicians and researchers via a simple to use interface for data management and analysis. PUBLIC HEALTH RELEVANCE: Flow cytometry is used in clinical research and for diagnosis and monitoring of patients with diseases ranging from cancer to autoimmunity. In this grant, we propose to enhance a previously built web-based software analysis suite, called Cytobank, to make all aspects of data management and analysis clinically compliant under 21 CFR Part 11. This will enable important new tools developed in the research laboratory to be translated into clinical settings and enhance patient treatment with cutting edge flow cytometry assays.