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: 10254335
• 负责人: Liang Li
• 金额: $ 232.4万
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10254335
• 关键词: Address; Adherence; Adopted; Amendment; Ancillary Study; Biological Specimen Banks; Chronic; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Complex; Contracts; Data; Data Collection; Data Management Resources; Development; Diabetes Mellitus; Discipline; Documentation; Educational workshop; Electronic Mail; Evaluation; Follow-Up Studies; Incidence; Infrastructure; Institution; Institutional Review Boards; Intervention; Investigation; Knowledge; Leadership; Logistics; Longitudinal cohort study; Maintenance; Malignant Neoplasms; Malignant neoplasm of pancreas; Manuals; Manuscripts; Methodology; Monitor; Participant; Patients; Persons; Phase; Policies; Preparation; Prevention; Procedures; Protocols documentation; Public Health; Quality Control; Quality of life; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Rest; Scientist; Secure; Site; Statistical Data Interpretation; System; Testing; Therapeutic Trials; Time; Training; United States National Institutes of Health; Update; biomarker development; biomarker discovery; biomarker validation; burden of illness; chronic pancreatitis; clinical center; cost; data management; data quality; data submission; design; detection method; disorder prevention; effective intervention; follow-up; innovation; meetings; novel; operation; organizational structure; protocol development; quality assurance; sample collection; screening; service providers; success; symposium; validation studies; web site; working group

Project Summary 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 (PDAC), and evaluation of novel intervention strategies; robust and high- quality data and specimen collection; and rigorous study execution of Consortium collaborative protocols. In the last four and a half years, the Coordination and Data Management Center (CDMC) has provided strong scientific, administrative, regulatory, managerial, logistic, and analytic supports to the Consortium, enabling the successful launch of three longitudinal cohort studies (i.e., PROCEED, INSPPIRE 2, and NOD) that aim to understand the relationship between CP, DM, and PDAC; and two other studies (i.e., DETECT and DEPICT (in planning)) that aim to better define and characterize Type 3c diabetes (T3cDM). In the next five years, the overall CDMC aim is to further refine and optimize the center's time-tested infrastructure, operations procedures, and organizational structure to provide strong and continual supports to the Consortium's existing and new studies, and address any emerging challenges associated with the progress of the studies from the accrual phase to the follow- up and dissemination phases. Specifically, we aim to (i) provide operation and coordination of the Consortium; (ii) provide supports to continue the accrual and follow up of patients in Consortium-approved studies; (iii) provide the infrastructure for biomarker development, prevention studies, and therapeutic trials; and (iv) design and support new studies and disease prevention.

项目摘要 慢性胰腺炎、糖尿病和糖尿病研究联盟成功的关键 胰腺癌(联盟)在于有效的沟通和协作 多学科的科学家；为发现和验证生物标志物而进行的强有力的研究设计 描述慢性胰腺炎(CP)、糖尿病(DM)、 和胰腺癌(PDAC)，以及对新的干预策略的评估； 高质量的数据和样本收集；以及财团合作的严格研究执行 协议。在过去的四年半里，协调和数据管理中心 (CDMC)提供了强大的科学、行政、法规、管理、后勤和 对财团的分析支持，使三个纵向队列得以成功启动 旨在了解这种关系的研究(即，INSPPIRE 2和NOD) CP、DM和PDAC之间的关系；以及其他两项研究(即，检测和描述(规划中)) 旨在更好地定义和描述3c型糖尿病(T3cDM)。在未来的五年里， CDMC的总体目标是进一步完善和优化该中心久经考验的基础设施， 运营程序和组织结构，以提供强大和持续的 支持该联盟现有的和新的研究，并解决任何新出现的问题 与研究从应计阶段到后续阶段的进展有关的挑战-- UP和传播阶段。具体地说，我们的目标是：(I)提供业务和协调 (Ii)提供支援，以继续评估和跟进下列病人： 联盟批准的研究；(3)为生物标记物开发提供基础设施； 预防研究和治疗试验；以及(4)设计和支持新的研究和疾病 预防。