Clinical Islet Transplantation: Data Coordinating Center

The summary for the Clinical Islet Transplantation: Data Coordinating Center grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

Clinical Islet Transplantation: Data Coordinating Center: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Allergy and Infectious Diseases (NIAID) invite applications for a Data Coordinating Center (DCC) to participate in a consortium of investigators and institutions that will perform clinical studies of islet transplantation in patients with type 1 diabetes mellitus (T1D). This consortium will develop and implement a program of single- and/or multi-center clinical trials, accompanied by mechanistic studies, in islet transplantation with or without accompanying kidney transplantation, for the treatment of T1D. Successful applicants for the DCC, together with Clinical Centers (see below), will constitute a Clinical Islet Transplantation (CIT) consortium whose aim is to design and implement human islet transplantation studies that will result in an improved treatment of T1D. The CIT Data Coordinating Center (CIT-DCC) will provide a broad range of support services for the CIT, including statistical, monitoring, and operational support. It will also assist with the preparation of DSMB reports, scientific manuscripts, and other reports and documents as needed to support the work and goals of the clinical centers in the consortium and/or as required by the NIH. The goals of the consortium, which are elaborated in a complementary solicitation (RFA DK-04-005), include the following: (1) Develop a scientific agenda for clinical and mechanistic studies in islet transplantation that is consistent with the research objectives described in this RFA. (2) Design and implement studies consistent with the scientific agenda. These studies may be performed by single centers within the consortium or by multiple centers implementing a single protocol, as required by the study design. (3) Share information and resources that will advance the field of islet transplantation. Institutions applying to become Clinical Centers under RFA DK-04-005) may also apply for the CIT-DCC solicited under this RFA (DK-04-004). In order to ensure that data analysis is done independently of data acquisition, the CIT-DCC cannot have overlap in personnel with a CIT-CC. An institution may apply for both a CIT-CC and the CIT-DCC, but each application must have separate principal investigators and include a specific plan documenting how the independent operation (i.e., confidentiality of the study-wide data) of each unit will be maintained.