Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium

急性胰腺炎联盟 1 型糖尿病数据协调中心

• 批准号: 10461052
• 负责人: Vernon M Chinchilli
• 金额: $ 395.07万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-17 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10461052
• 关键词: Accountability; Acute; Adherence; Adverse event; Agreement; Ancillary Study; Area; Autoantibodies; Autoimmune Process; Biological; Biological Factors; Biological Markers; Clinical; Clinical Trials; Collection; Common Data Element; Conflict of Interest; Contracts; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Management Resources; Data Set; Development; Devices; Diabetes Mellitus; Disease Progression; Documentation; Electronic Health Record; Endocrinology; Enrollment; Ensure; Environmental Risk Factor; Etiology; Functional disorder; Funding; Gastroenterology; Genetic; Genomics; Geography; Grant; Health; Health Insurance Portability and Accountability Act; Health Sciences; Immune; Incidence; Inflammatory; Information Dissemination; Infrastructure; Institutes; Institutional Review Boards; Insulin-Dependent Diabetes Mellitus; Internet; Laboratories; Lead; Longitudinal observational study; Manuscripts; Medical; Medicine; Monitor; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Pancreas; Pancreatitis; Parents; Patients; Pennsylvania; Persons; Population Heterogeneity; Preparation; Procedures; Process; Protocols documentation; Public Health; Publications; Quality Control; Recording of previous events; Reporting; Research Design; Research Personnel; Risk; Risk Factors; Role; Safety; Safety Management; Sample Size; Sampling; Security; Services; Severities; Site Visit; Statistical Data Interpretation; Subgroup; Support System; System; Testing; Therapeutic; Time; United States National Institutes of Health; Universities; Validation; Vertebral column; Visit; acute pancreatitis; base; biobank; biomarker development; clinical center; cohort; college; comorbidity; cost; data exchange; data management; data standards; data submission; drug distribution; early detection biomarkers; expectation; experience; genetic risk factor; impaired glucose tolerance; insight; multidisciplinary; novel; participant enrollment; potential biomarker; programs; prospective; quality assurance; randomized trial; recruit; research study; response; user-friendly; web site

ABSTRACT Type 1 diabetes mellitus (T1D) may develop after, or as a consequence of, one or more acute pancreatitis episodes. Elucidation of early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D can help inform best practices in treatment for reducing incidence of T1D onset. In response to the National Institute of Diabetes and Digestive and Kidney Diseases’ RFA-DK-19- 023, the Departments of Public Health Sciences (DPHS) and Medicine (Endocrinology and Gastroenterology) at The Pennsylvania State University College of Medicine and the Allegheny Health Network propose to serve as the Data Coordinating Center (DCC) for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). One DCC and 10 Clinical Centers (RFA-DK-19-022) will form the clinical consortium, T1DAPC. An efficient and supportive DCC not only collaborates on development of all documentation and provides efficient statistical analyses and Trial Master File, the results from the DCC form the backbone of numerous publications, preliminary data for subsequent trials, and may lead to profound novel insights from ad-hoc, post-hoc, and newly formulated analyses to Questions arising during the study. DPHS has vast experience and expertise as the DCC for 10 NIH-funded clinical trial and five observational study research networks, which resulted in more than 200 publications, six subsequent grants. Our vast experience in DCC for HIPAA-compliant data compilation and analyses of multicenter clinical trials spans more than a dozen therapeutic areas and can provide additional insights for analysis of ethnically and geographically diverse population of subjects as well as development and analyses of distinct and overlapping clinical profiles, some being instituted post hoc with development and testing cohorts. The DCC will aggregate and analyze all common data elements and samples and provide scientific infrastructure and administrative support in a clear, concise, friendly manner for the T1DAPC Consortium. The DCC and the Clinical Centers will form multi-disciplinary teams that execute a prospective longitudinal observational study that can determine the incidence of T1 diabetes associated with an acute pancreatitis episode and assess relationships with potential early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D or other types of diabetes. The DCC will collect, synthesize, and disseminate main findings and lessons learned from the T1DAPC parent and ancillary studies, create public data sets, and share the biological samples in accordance with the NIDDK and T1DAPC.

抽象的 1型糖尿病（T1D）可能是在一个或多个急性胰腺炎之后或结果出现的 阐明早期生物标志物，临床体征，疾病进展的生物标志物，免疫和免疫标志物 遗传危险因素，大多数易感亚组，降水机制，急性胰腺炎的病因和 T1D相关的病理生理学可以帮助您为减少事件的治疗方法提供最佳实践 T1D发作。为了回应美国国家糖尿病与消化研究所和肾脏疾病的RFA-DK-19-- 023，公共卫生科学部（DPHS）和医学（内分泌学和胃肠病学） 在宾夕法尼亚州立大学医学院和阿勒格尼健康网络提案中 作为急性胰腺炎联盟（T1DAPC）中1型糖尿病的数据协调中心（DCC）。 一个DCC和10个临床中心（RFA-DK-19-022）将形成临床财团，T1DAPC。有效的 支持性DCC不仅在所有文档的开发方面合作，并提供有效的统计信息 分析和试用主文件，DCC的结果形成了许多出版物的骨干， 后续试验的初步数据，并可能导致临时，事后和 新提出的分析是针对研究期间出现的问题。 DPHS具有丰富的经验和专业知识 DCC用于10项NIH资助的临床试验和5个观察性研究网络，这导致了更多 超过200个出版物，随后的六个赠款。我们在DCC中获得符合HIPAA的数据的丰富经验 多中心临床试验的汇编和分析跨越了十几个治疗领域，可以 提供其他见解，以分析种族和地理上不同的受试者人群 作为对独特和重叠临床特征的开发和分析，有些是由 开发和测试队列。 DCC将汇总和分析所有常见数据元素，并 样本并以明确，简洁，友好的方式提供科学基础设施和行政支持 T1DAPC财团。 DCC和临床中心将组成执行的多学科团队 可以确定与T1糖尿病的事件的前瞻性纵向观察研究 急性胰腺炎发作和与潜在的早期生物标志物，临床体征的评估关系， 疾病进展，免疫和遗传危险因素的生物标志物，大多数易感亚组，沉淀 急性胰腺炎的机制，病因以及T1D或其他类型的相关病理生理学 糖尿病。 DCC将收集，合成和传播从中学到的主要发现和经验教训 T1DAPC父母和辅助研究，创建公共数据集并按照 与NIDDK和T1DAPC。