Clinical Islet Transplantation: Data Coordinating Center

临床胰岛移植：数据协调中心

基本信息

批准号：
7496955
负责人：
William R. Clarke
金额：
$ 330.71万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-30 至 2009-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7496955
关键词：
Address Allografting Autoimmunity Biometry Certification Clinical Clinical Investigator Clinical Trials Collaborations Contracts Data Data Analyses Data Coordinating Center Data Quality Data Set Databases Diabetes Mellitus Drug Packaging Ensure Financial Activity Goals Immunotherapy Insulin-Dependent Diabetes Mellitus Internal Medicine Intervention Iowa Islets of Langerhans Transplantation Laboratories Leadership Manuscripts Monitor Multi-Institutional Clinical Trial Nephrology Neurology Online Systems Patients Preparation Procedures Progress Reports Protocols documentation Public Health Publications Randomized Records Recruitment Activity Recurrence Reporting Research Research Design Research Personnel Safety Secure Site Source Specimen System Teleconferences Toxic effect Training Travel United States Food and Drug Administration United States National Institutes of Health Universities Work clinical epidemiology college data acquisition data management database design design distributed data experience improved islet member protocol development quality assurance repository symposium

项目摘要

DESCRIPTION (provided by applicant): The Clinical Trials Statistical and Data Management Center (CTSDMC) in the Department of Biostatistics, College of Public Health at The University of Iowa in collaboration with the Department of Internal Medicine proposes to establish and operate the Data Coordinating Center (DCC) for the Clinical Islet Transplantation: Data Coordinating Center (RFA -DK-04-004). This CTSDMC will work with the study clinical centers, and NIH to develop and execute important clinical investigations to help address the consortium's goals to develop and execute important mechanistic and clinical investigations to understand and improve islet cell transplantation in patients with type I diabetes. We will use our study design, statistical, data management, and study coordination experience and expertise to help the consortium examine ways to (1) increasing the efficiency of islet transplantation; (2) improving immunotherapy to reduce toxicity, recurrent autoimmunity and allograft rejection; and (3) to develop interventions to reduce the local complications of the islet administration procedure. Our group brings over 30 years of experience in the design and implementation clinical and epidemiology studies and over 14 years experience serving as the data coordinating center for multi-center clinical trials. These studies include studies in neurology, nephrology, and diabetes. We represent an experienced and productive team of investigators who have worked together for many years. The CTSDMC staff has; successfully developed and operated web based data entry systems and databases for multi-center trials and have an excellent record in successfully coordinating clinical trials.

DESCRIPTION (provided by applicant): The Clinical Trials Statistical and Data Management Center (CTSDMC) in the Department of Biostatistics, College of Public Health at The University of Iowa in collaboration with the Department of Internal Medicine proposes to establish and operate the Data Coordinating Center (DCC) for the Clinical Islet Transplantation: Data Coordinating Center (RFA -DK-04-004). 该CTSDMC将与研究临床中心合作，NIH开发和执行重要的临床研究，以帮助解决该联盟的目标，以开发和执行重要的机械和临床研究，以了解和改善I型糖尿病患者的胰岛细胞移植。我们将使用我们的研究设计，统计，数据管理和研究协调经验和专业知识来帮助该财团研究（1）提高胰岛移植效率的方法；（2）改善免疫疗法以降低毒性，复发性自身免疫性和同种异体移植排斥；（3）制定干预措施以减少胰岛给药程序的局部并发症。我们的小组在设计和实施临床和流行病学研究中带来了30多年的经验，以及14年以上的经验，作为多中心临床试验数据协调中心。这些研究包括神经病学，肾脏病和糖尿病的研究。我们代表了一支经验丰富且富有成效的调查员团队，他们共同工作了很多年。 CTSDMC工作人员拥有；成功地开发和操作了基于Web的数据输入系统和数据库，用于多中心试验，并在成功协调临床试验方面具有出色的记录。