Clinical Islet Transplantation: Data Coordinating Center

描述(由申请人提供)：爱荷华大学公共卫生学院生物统计系的临床试验统计和数据管理中心(CTSDMC)与内科医学院合作，建议建立和运营临床胰岛移植数据协调中心(DCC)：数据协调中心(RFA-DK-04-004)。 CTSDMC将与研究临床中心和NIH合作，开发和执行重要的临床研究，以帮助实现该联盟的目标，即开发和执行重要的机械性和临床研究，以了解和改进I型糖尿病患者的胰岛细胞移植。我们将利用我们的研究设计、统计、数据管理和研究协调经验和专业知识，帮助该财团研究如何(1)提高胰岛移植的效率；(2)改进免疫疗法，以减少毒性、反复的自身免疫和同种异体移植排斥反应；以及(3)开发干预措施，以减少胰岛给药程序的局部并发症。 我们的团队在临床和流行病学研究的设计和实施方面拥有30多年的经验，并作为多中心临床试验的数据协调中心拥有14年以上的经验。这些研究包括神经学、肾脏学和糖尿病的研究。我们代表着一支经验丰富、富有成效的调查团队，他们在一起工作了多年。CTSDMC的工作人员成功地开发和操作了基于网络的多中心试验数据录入系统和数据库，并在成功协调临床试验方面取得了良好的记录。

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.