Clinical Imaging and Data Resources Core

临床影像和数据资源核心

• 批准号: 10334984
• 负责人: Kathleen N. Moore
• 金额: $ 29.92万
• 依托单位: UNIVERSITY OF OKLAHOMA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-15 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10334984
• 关键词: Address; Animal Model; Archives; Awareness; Biological Specimen Banks; Biomedical Engineering; Biometry; Biostatistics Core; Cancer Center; Cancer Research Project; Centers of Research Excellence; Clinical; Clinical Data; Clinical Research; Collaborations; Communities; Computer software; Cost effectiveness research; Data; Data Analyses; Databases; Development; Educational workshop; Engineering; Ensure; Evaluation Indexes; Face; Faculty; Goals; Health Sciences; Histopathology; Image; Imaging technology; Infrastructure; Institutional Review Boards; Joints; Knowledge; Leadership; Learning; Link; Magnetic Resonance Imaging; Medical Imaging; Medical center; Metadata; Methodology; Methods; Modeling; Monitor; Oklahoma; Pathologist; Performance; Policies; Prospective Studies; Protocols documentation; Publishing; Regulation; Research; Research Methodology; Research Personnel; Research Project Grants; Research Support; Resources; Retrospective Studies; Sample Size; Sampling; Sampling Studies; Secure; Services; Slide; Stains; Statistical Data Interpretation; Study models; Testing; The Cancer Imaging Archive; Training; Training Support; Translational Research; Treatment outcome; United States National Institutes of Health; Universities; Validation; Vertebrates; Writing; biomedical imaging; cancer diagnosis; central database; clinical biomarkers; clinical imaging; college; cost effectiveness; data resource; design; digital; experimental study; graphical user interface; human subject; human subject protection; imaging biomarker; imaging study; informatics infrastructure; machine learning method; machine learning model; member; operation; performance tests; programs; quantitative imaging; radiological imaging; radiologist; radiomics; shared database; statistics; success; translational cancer research; welfare

ABSTRACT – Clinical Imaging and Data Resources Core The overarching objective of this Clinical Imaging and Data Resources Core (CIDRC) is to provide research project leaders (RPLs) of this COBRE with both regulatory and scientific support to facilitate their effort to conduct medical imaging related translational cancer research projects. The CIDRC will serve as a crucial bridge between the biomedical imaging research performed in the Gallogly College of Engineering on the University of Oklahoma (OU) Norman campus and the clinical research community in the Stephenson Cancer Center (SCC) on the OU Health Science Center (OUHSC) campus. Establishment of a robust, secure and durable mechanism and platform for storing and sharing images, clinical samples, and associated data is critical to the development and success of this proposed COBRE. The CIDRC will be organized to ensure the availability of scientifically valid and well-characterized image data, and the compliance with all NIH regulatory requirements in conducting human subject and animal model studies, as well as to encourage broad collaborative research efforts between the biomedical imaging engineering and clinical research. The CIDRC will be established in the SCC of OUHSC campus because OUHSC provides the broad clinical research service including the Institutional Review Board (IRB) to examine and approve translational clinical research projects, the biostatistics Core, and services to retrieve the archived medical images and the H&E stained histopathology slides, and other clinical data of cancer diagnosis results and treatment outcome. This CIDRC will integrate and strengthen the existing clinical research supporting resources located on the OUHSC campus to build a new and unique research resource platform to train and support the RPLs and pilot awardees of this COBRE to conduct joint translational cancer research projects on two OU campuses. The overall operation of the CIDRC will include to: (1) ensure that RPLs fully understand all NIH policies and regulations for protection of human subjects and welfare of vertebrate animals, (2) certify that study protocols for both retrospective and prospective studies are fully compliant with all NIH- mandated regulatory requirements, (3) assist with the IRB protocol application writing and submission, (4) provide biostatistics support to confirm that experiments are designed with appropriate sample sizes or statistical power and the proper statistical data analysis methodologies are used to test and validate the underlying hypothesis with high scientific rigor, and (5) establish a unique platform that can provide RPLs and other researchers with the shared databases allowing access to the linked annotated medical images, biospecimens and clinical data necessary to facilitate their proposed research projects. Thus, the CIDRC will build a critical scientific and intellectual support infrastructure that aims to ensure the success of this COBRE as the RPLs make progress in their research projects and transition to the independent researchers in conducting medical imaging related translational cancer research with the high clinical impact and scientific rigor.

摘要 – 临床影像和数据资源核心 该临床影像和数据资源核心 (CIDRC) 的总体目标是提供研究 该 COBRE 的项目负责人 (RPL) 获得监管和科学支持，以促进他们开展工作 CIDRC 将成为与医学影像相关的转化癌症研究项目之间的重要桥梁。 俄克拉荷马大学加洛格利工程学院进行的生物医学成像研究 (OU) 诺曼校区和 OU 斯蒂芬森癌症中心 (SCC) 的临床研究社区 健康科学中心 (OUHSC) 校园建立健全、安全和持久的机制。 用于存储和共享图像、临床样本和相关数据的平台对于开发和共享至关重要 CIDRC 将组织该提议的 COBRE 的成功，以确保提供科学有效的数据。 和良好表征的图像数据，以及在进行时遵守所有 NIH 监管要求 人类受试者和动物模型研究，以及鼓励之间广泛的合作研究工作 生物医学影像工程和临床研究中心将设立在OUHSC的SCC。 因为 OUHSC 提供广泛的临床研究服务，包括机构审查委员会 （IRB）审查和批准转化临床研究项目、生物统计学核心和服务 检索存档的医学图像和 H&E 染色的组织病理学幻灯片以及其他癌症临床数据 本次CIDRC将整合和加强现有的临床研究。 支持位于 OUHSC 校园的资源，建立一个新的、独特的研究资源平台 培训和支持 RPL 和 COBRE 试点获奖者进行联合转化癌症研究 CIDRC 的总体运作将包括： (1) 确保 RPL 得到充分落实。 了解 NIH 关于保护人类受试者和脊椎​​动物福利的所有政策和法规， (2) 证明回顾性和前瞻性研究的研究方案完全符合所有 NIH- 强制性监管要求，(3) 协助 IRB 协议申请的撰写和提交，(4) 提供生物统计学支持，以确认实验设计有适当的样本量或统计数据 使用力量和适当的统计数据分析方法来测试和验证底层 具有高度科学严谨性的假设，以及（5）建立一个独特的平台，可以提供 RPL 和其他 具有共享数据库的研究人员可以访问链接的带注释的医学图像、生物样本 以及促进其拟议研究项目所需的临床数据，因此，CIDRC 将建立一个关键的研究中心。 旨在确保 COBRE 作为 RPL 取得成功的科学和智力支持基础设施 研究项目取得进展，并过渡为从事医学研究的独立研究人员 影像相关的转化癌症研究具有较高的临床影响力和科学严谨性。