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

• 批准号: 10208881
• 负责人: Catherine A Spino
• 金额: $ 143.96万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10208881
• 关键词: Accounting; Adherence; Adverse event; Architecture; Area; Behavioral; Biological Markers; Budgets; Chronic Disease; Clinical; Clinical Research; Cohort Studies; Collaborations; Collection; Communication; Complement; Complex; Complications of Diabetes Mellitus; Custom; Data; Data Analyses; Data Analytics; Data Collection; Data Coordinating Center; Databases; Diabetes Mellitus; Diabetic Foot; Diagnostic; Disease; Ensure; Esapent; FDA approved; Foot Ulcer; Functional disorder; Goals; Heterogeneity; Infrastructure; Institutional Review Boards; Intervention; Laboratories; Leadership; Learning; Manuals; Methods; Michigan; Modeling; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Online Systems; Patients; Preparation; Prevention; Procedures; Protocols documentation; Psychosocial Factor; Recurrence; Reporting; Reproducibility; Research; Research Design; Research Personnel; Risk; Sampling Biases; Science; Secure; Services; Statistical Data Interpretation; Statistical Methods; Subgroup; Support System; System; Techniques; Technology; Teleconferences; Therapeutic; Time; TimeLine; Translating; Translations; Universities; base; bench to bedside; biomarker discovery; biomarker validation; clinical biomarkers; clinical research site; clinically relevant; comorbidity; data management; data standards; design; experience; healing; health care delivery; meetings; member; model design; operation; prevent; programs; recruit; safety study; success; tool; validation studies; web site; webinar

Diabetes-related foot ulcers (DFUs) are prevalent and devastating complications of diabetes, with few FDA-approved technologies and therapies to promote successful healing or prevention. The Diabetic Foot Consortium (DFC) represents the first-of-its-kind multi-site clinical research effort in the US to elucidate biomarkers that promote DFU healing and prevent recurrence. Given the multiplicity and complexity of known factors contributing to non-healing (including biomarkers, disease state, health care delivery, interventions, behavioral and psychosocial factors), the breadth and diversity of experience and expertise of the six clinical sites chosen as DFC clinical research units (CRUs) are essential to achieve the objectives of the consortium. Rigorous design, accompanied by thoughtful statistical analyses, of biomarker validation studies are also critical to accomplish DFC goals. With more than 20 years of experience, the University of Michigan data coordinating center (DCC) brings together an exemplary research group. DCC investigators have relevant experience in diabetes complications and co-morbidity modeling, design and analysis of chronic diseases, biomarker discovery and validation, and FDA collaborations. Strong statistical leadership complements the clinical and laboratory expertise of the DFC, leading to enhanced understanding of the pathophysiology of DFU healing, dissemination of clinically relevant results, and preparation for translational clinical studies. The overarching goal of the DCC is to assist and collaborate with clinical research and biomarker analysis unit investigators, the DFC steering committee, and NIDDK program staff to enable successful implementation and completion of the clinical study protocols approved by the DFC, and advise and execute biomarker validation analyses. We will accomplish these goals through by 1) providing infrastructure and services to the DFC, tailored for their goals. This will ensure seamless study administration and operations for all DFC studies, and promote effective communication among DFC stakeholders. 2) We will ensure the collection of timely, accurate and reproducible data and maximize adherence to study protocols by providing expert statistical design, efficient database architecture, and effective study coordination. 3) We will conduct statistical data analyses and disseminate research findings with scientific rigor for biomarker qualification using the most up-to-date statistical methods. 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 maximization of the 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。 FDA 批准的技术和疗法可促进成功治愈或预防。糖尿病足 联盟 (DFC) 代表了美国首个此类多中心临床研究工作，旨在阐明 促进 DFU 愈合并预防复发的生物标志物。鉴于已知的多样性和复杂性 导致不愈合的因素（包括生物标志物、疾病状态、医疗保健服务、干预措施、 行为和社会心理因素），六个临床经验和专业知识的广度和多样性 被选为 DFC 临床研究单位 (CRU) 的地点对于实现联盟的目标至关重要。 生物标志物验证研究的严格设计以及深思熟虑的统计分析是 对于实现 DFC 目标也至关重要。密歇根大学数据拥有20多年的经验 协调中心（DCC）汇集了一个模范研究小组。 DCC调查人员有相关 糖尿病并发症和共病建模、慢性病设计和分析方面的经验， 生物标志物的发现和验证以及 FDA 合作。强大的统计领导力补充了 DFC 的临床和实验室专业知识，有助于加深对 DFU 病理生理学的了解 治愈、传播临床相关结果以及转化临床研究的准备。这 DCC 的总体目标是协助临床研究和生物标志物分析部门并与之合作 调查员、DFC 指导委员会和 NIDDK 项目工作人员，以确保成功实施和 完成 DFC 批准的临床研究方案，并建议和执行生物标志物验证 分析。 我们将通过以下方式实现这些目标： 1) 为 DFC 提供量身定制的基础设施和服务 为了他们的目标。这将确保所有 DFC 研究的无缝研究管理和运营，并促进 DFC 利益相关者之间的有效沟通。 2）我们将确保收集及时、准确、 通过提供专家统计设计、高效的数据重复性数据并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）我们将进行统计数据分析和 使用最新的技术传播具有科学严谨性的生物标志物鉴定研究成果 统计方法。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化为临床，并最大限度地发挥临床影响 这个复杂且具有挑战性的治疗领域的联盟。