Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer: Coordinating and Data Management Center (CSCPDPC-CDMC)

慢性胰腺炎、糖尿病和胰腺癌研究联盟：协调和数据管理中心 (CSCPDPC-CDMC)

• 批准号: 10012989
• 负责人: Liang Li
• 金额: $ 7.27万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-28 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10012989
• 关键词: Adherence; Adult; Biometry; Child; Clinic; Clinical; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communities; Complex; Computer Analysis; Computer software; Computing Methodologies; Consultations; Data; Data Collection; Data Quality; Detection; Diabetes Mellitus; Discipline; Educational workshop; Evaluation; Evaluation Studies; Gastroenterology; Intervention; Leadership; Logistics; Malignant Neoplasms; Malignant neoplasm of pancreas; Manuals; Manuscripts; Medicine; Methodology; Methods; Minnesota; Molecular; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Newly Diagnosed; Operative Surgical Procedures; Pathology; Patients; Preparation; Prevention; Procedures; Protocols documentation; Public Health; Quality Control; Reporting; Research; Research Design; Research Personnel; Risk; Scientist; Screening for cancer; Secure; Site; Specimen; Statistical Data Interpretation; Statistical Methods; System; Telephone; Universities; University of Texas M D Anderson Cancer Center; Work; biomarker evaluation; biomarker validation; chronic pancreatitis; cohort; data management; data submission; effective intervention; experience; meetings; molecular pathology; novel; operation; protocol development; public health relevance; quality assurance; repository; response; sample collection; success; symposium; web site

 DESCRIPTION (provided by applicant): A key to the success of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (Consortium) lies in effective communication and collaboration among scientists in multiple disciplines; strong study design for discovery and validation of biomarkers characterizing complex interactions between chronic pancreatitis (CP), diabetes mellitus (DM), and pancreatic cancer (PC) and evaluation of novel intervention strategies; and rigorous study execution of Consortium collaborative protocols. The overall aims of the proposed Coordination and Data Management Center (CDMC) are to (i) provide coordination of the Consortium in order to enhance communication and collaboration among Consortium investigators and with the larger scientific communities; (ii) provide scientific and statistical leadership for the Consortium in research strategy, study design approaches, and statistical and computational methods; and iii) coordinate Consortium collaborative studies. Under the direction of the Consortium Steering Committee (SC), the CDMC will 1) perform network coordination and promote collaborations among scientific investigators by providing support for Consortium meetings, SC, subcommittees, and Data Safety and Monitoring Board, developing and maintaining Consortium secured websites and listservs, and producing and maintaining all Consortium documents; 2) promote and develop proper study design approaches and analysis strategies for Consortium studies, provide statistical software to implement these strategies, provide statistical and computational support for Consortium collaborative studies, apply or develop novel statistical methods relevant to Consortium needs, in particular methods for dynamic prediction of PDAC risk in the Consortium cohort, methods for handling informative censoring in the Consortium cohort, and methods for group sequential biomarker evaluations; and 3) support Consortium collaborative studies by developing and maintaining the study data management system, working with Consortium investigators on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimens; and performing QA/QC and study evaluation; providing input on appropriate interpretation of study findings and reports; supporting the formation of distribution of Consortium biospecimen repositories; support preparations of documentations to FDA for Consortium INDs/IVDs, and providing a mechanism for rapid and routine information sharing among Consortium investigators and NIDDK/NCI staff.

 描述（由申请人提供）：慢性胰腺炎、糖尿病和胰腺癌研究联盟（联盟）成功的关键在于多学科科学家之间有效的沟通和合作，以发现和验证生物标志物；描述慢性胰腺炎（CP）、糖尿病（DM）和胰腺癌（PC）之间复杂的相互作用，并评估新的干预策略和联盟协作的严格研究执行；拟议的协调和数据管理中心（CDMC）的总体目标是（i）提供联盟的协调，以加强联盟研究人员之间以及与更大的科学界的沟通和合作；（ii）提供科学和统计数据；在联盟指导委员会 (SC) 的指导下，CDMC 将 1) 进行网络协调并促进合作。通过为联盟会议、SC、小组委员会和数据安全和监测委员会提供支持，开发和维护联盟安全网站和列表服务器，以及制作和维护所有联盟文件，在科学研究人员中发挥作用；2) 促进和开发适当的研究设计方法和分析策略；对于联盟研究，提供统计软件来实施这些策略，为联盟合作研究提供统计和计算支持，应用或开发与联盟需求相关的新颖统计方法，特别是动态预测联盟中PDAC风险的方法队列、处理联盟队列中信息审查的方法以及组序贯生物标志物评估方法；3) 通过开发和维护研究数据管理系统、与联盟研究人员合作进行研究设计、方案开发、数据表格来支持联盟合作研究；协调和监测研究；并进行质量保证/质量控制和研究评估；提供对研究结果和报告的适当解释的支持；为联盟 IND/IVD 向 FDA 准备文件，并为联盟研究人员和 NIDDK/NCI 工作人员之间提供快速、常规信息共享的机制。