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: 10672905
• 负责人: Vernon M Chinchilli
• 金额: $ 389.57万
• 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/10672905
• 关键词: Accountability; Acute; Adherence; Adverse event; Agreement; Ancillary Study; Area; Autoantibodies; Autoimmune Process; Biological; Biological Factors; Biological Markers; Clinical; Clinical Trials; Collaborations; 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; Ethnic Origin; Etiology; Friends; Functional disorder; Funding; Gastroenterology; Genetic; Genomics; Geography; Grant; Health; Health Insurance Portability and Accountability Act; Health Sciences; Immune; Incidence; Inflammatory; Information Dissemination; Infrastructure; Institutional Review Boards; Insulin-Dependent Diabetes Mellitus; Internet; Laboratories; Learning; 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; Predisposition; Preparation; Procedures; Process; Protocols documentation; Public Health; Publications; Qualifying; Quality Control; Randomized; 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; 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; 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.

摘要 1型糖尿病（T1 D）可能在一次或多次急性胰腺炎后发生，或作为其结果发生 情节。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 遗传风险因素、最易感亚组、诱发机制、急性胰腺炎病因，以及 T1 D的相关病理生理学可以帮助提供治疗的最佳实践，以降低T1 D的发病率。 T1 D发作。为了响应国家糖尿病、消化和肾脏疾病研究所的RFA-DK-19- 023，公共卫生科学系（DPHS）和医学系（内分泌学和胃肠病学） 宾夕法尼亚州立大学医学院和阿勒格尼健康网络提出， 作为1型糖尿病急性胰腺炎联盟（T1 DAPC）的数据协调中心（DCC）。 一个DCC和10个临床中心（RFA-DK-19-022）将组成临床联盟T1 DAPC。高效和 支持性的DCC不仅在所有文件的编制方面进行合作， 分析和试验主文件，DCC的结果构成了许多出版物的支柱， 初步数据，为后续试验，并可能导致深刻的新见解，从特设，事后， 对研究过程中出现的问题进行新的分析。DPHS拥有丰富的经验和专业知识， DCC为10个NIH资助的临床试验和5个观察性研究网络，这导致了更多 200多篇出版物，6次后续赠款。我们在符合HIPAA的数据DCC方面的丰富经验 多中心临床试验的汇编和分析跨越十几个治疗领域， 还为分析受试者的种族和地理多样性提供了更多见解 作为不同和重叠的临床特征的开发和分析，有些是事后制定的， 开发和测试队列。DCC将汇总和分析所有通用数据元素， 样品，并以清晰、简洁、友好的方式提供科学基础设施和行政支持， T1 DAPC联盟DCC和临床中心将组成多学科团队， 一项前瞻性纵向观察性研究，可以确定与以下因素相关的T1糖尿病的发病率： 急性胰腺炎发作，并评估与潜在的早期生物标志物，临床体征， 疾病进展的生物标志物，免疫和遗传风险因素，最易感亚组， 急性胰腺炎的发病机制、病因学以及T1 D或其他类型胰腺炎的相关病理生理学， 糖尿病发展协调委员会将收集、综合和传播 T1 DAPC母研究和辅助研究，创建公共数据集，并根据 NIDDK和T1 DAPC。