University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

密歇根大学糖尿病足联盟数据协调中心

基本信息

批准号：
10877641
负责人：
Catherine A Spino
金额：
$ 13.89万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-01 至 2027-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10877641
关键词：
Accounting Adherence Adverse event Ancillary Study Architecture Area Bioinformatics Biological Markers Budgets Caring Characteristics Chronic Disease Clinical Clinical Research Collaborations Collection Communication Complement Complex Complications of Diabetes Mellitus Contracts Data Data Analyses Data Analytics Data Collection Data Coordinating Center Databases Diabetes Mellitus Diabetic Foot Diabetic Foot Ulcer Diagnostic Ensure Esapent FDA approved Foot Ulcer Foundations Future Goals Health Heterogeneity Infrastructure Institutional Review Boards Knowledge Laboratories Leadership Learning Measurement Methods Michigan Modeling Monitor National Institute of Diabetes and Digestive and Kidney Diseases Observational Study Online Systems Outcome Patient-Focused Outcomes Patients Physicians Process Protocols documentation Qualifying Recurrence Reporting Reproducibility Research Personnel Sampling Biases Science Scientist Scoring Method Secure Services Site Statistical Methods Subgroup System Techniques Therapeutic Time Translations Universities bench to bedside biobank biomarker discovery biomarker validation comorbidity data integration data management design experience healing improved knowledge base machine learning method meetings operation patient subsets payment predictive marker prevent repository safety outcomes safety study social health determinants standard care standard of care study population success tool treatment adherence validation studies web site webinar wound

项目摘要

Diabetes-related foot ulcers (DFUs) are prevalent and devastating complications of diabetes, with few FDA-approved therapies. The Diabetic Foot Consortium (DFC) was established in 2018 as the first multi-site US clinical research effort to elucidate biomarkers that promote DFU healing and prevent recurrence. The multiplicity and complexity of known factors contributing to poor outcomes require the diversity of experience and expertise of the four DFC clinical research units (CRUs), the biomarker analysis units (BAUs), and the University of Michigan (UM) data coordinating center (DCC) to achieve the scientific objectives of the DFC. The DCC brings over 23 years of experience in statistical and operational leadership of complex studies and networks, leveraging specific experience in diabetes complications and co-morbidity modeling, design and analysis of chronic diseases, biomarker discovery and validation, and FDA collaborations. The DCC’s leadership in these areas complements the clinical and laboratory expertise of the DFC. Together we will identify important and reliable biomarkers that predict DFU healing and recurrence and study the association of patient and physician characteristics with good DFU outcomes. In our first 3 years, the DCC has built successful and durable partnerships with CRU and BAU investigators and NIDDK scientists to implement two biomarker validation studies and a biorepository study that collects biospecimens for future research. We will continue this partnership to complete these complex studies and finalize a platform study in patients with open DFUs that will support future biomarker studies, as well further our knowledge of the impact of standard of care therapies and social determinants of health on DFU outcomes. These activities will lay the foundation for future trials leading to better care and health outcomes for patients with DFUs. We will accomplish these goals by: 1) providing tailored infrastructure and services to ensure seamless administration and operations for all DFC studies and facilitate effective communication among DFC stakeholders; 2) ensuring the collection of timely, accurate and reproducible data and high-quality biospecimens and maximizing adherence to study protocols by providing expert statistical design, efficient database architecture, and effective study coordination; 3) applying state-of-the-art bioinformatics and statistical methods to analyze biomarker qualification, to detect important patient characteristics associated with good clinical outcomes, and to identify testable hypotheses to guide care for subpopulations of patients with DFUs. Completion of these aims by a highly experienced and accomplished UM DCC will result in translation of the validated biomarkers from bench to bedside, and improvements in standard of care based on comprehensive patient, foot ulcer and treatment data. Collaboration among the CRUs, BAUs, satellite sites, ancillary study investigators, NIDDK and DCC will maximize the scientific and clinical impact of the Consortium in this complex and challenging therapeutic area.

糖尿病相关足部溃疡 (DFU) 是糖尿病的常见且具有破坏性的并发症，很少有人会发生这种情况。糖尿病足联盟 (DFC) 成立于 2018 年，是第一个获得 FDA 批准的疗法。美国临床研究致力于阐明促进 DFU 愈合和预防复发的生物标志物。导致不良结果的已知因素的多样性和复杂性需要经验的多样性四个 DFC 临床研究单位 (CRU)、生物标志物分析单位 (BAU) 和密歇根大学 (UM) 数据协调中心 (DCC) 实现了 DFC 的科学目标。 DCC 在复杂性的统计和运营领导方面拥有超过 23 年的经验研究和网络，利用糖尿病并发症和共病建模的具体经验，慢性病的设计和分析、生物标志物的发现和验证以及 FDA 合作。 DCC 在这些领域的领导地位与 DFC 的临床和实验室专业知识相辅相成。将确定预测 DFU 愈合和复发的重要且可靠的生物标志物，并研究在我们的前 3 年中，DCC 已将患者和医生的特征与良好的 DFU 结局联系起来。与 CRU 和 BAU 研究人员以及 NIDDK 科学家建立了成功且持久的合作伙伴关系，以实施两项生物标志物验证研究和一项收集生物样本用于未来研究的生物样本库研究。将继续这种伙伴关系，以完成这些复杂的研究，并最终确定针对患有以下疾病的患者的平台研究开放的 DFU 将支持未来的生物标志物研究，并进一步了解标准的影响这些活动将为 DFU 结果奠定基础。为未来的试验带来更好的 DFU 患者护理和健康结果。我们将通过以下方式实现这些目标：1）提供量身定制的基础设施和服务，以确保无缝所有 DFC 研究的管理和运营，并促进 DFC 之间的有效沟通 2）确保收集及时、准确、可重复的数据和高质量的数据通过提供专家统计设计、高效的生物样本和最大限度地遵守研究方案数据库架构和有效的研究协调；3）应用最先进的生物信息学和统计方法来分析生物标志物资格，检测相关的重要患者特征具有良好的临床结果，并确定可检验的假设来指导对患者亚群的护理由经验丰富且卓有成就的 UM DCC 完成这些目标将导致：将经过验证的生物标志物从实验室转移到临床，并基于以下内容改进护理标准 CRU、BAU、卫星站点之间的综合患者、足部溃疡和治疗数据。辅助研究研究者、NIDDK 和 DCC 将最大限度地发挥联盟的科学和临床影响在这个复杂且具有挑战性的治疗领域。