Rho Federal Systems Division (RhoFED), proposes to become the new Statistical and Clinical Coordinating Center (SACCC) for the 3 NIAID-funded multi-investigator consortia investigating the mechanisms of solid organ transplantation: CTOT, CTOT-C and GTCRP. Together, the PI and RhoFED provide a wealth of experience leading numerous statistical, clinical, and data coordinating centers funded under both grant and contract mechanisms by NIAID, NHLBI, and NIDCR. In addition, RhoFED recently transitioned the Statistical and Data Coordinating Center (SDCC) contract for the Immune Tolerance Network (ITN) from PPD, so it is well-qualified to transition the SACCC from PPD to RhoFED with as little disruption in the activities of the collaborating consortia as possible. The Offerors have the following Specific Aims: (1) to provide experienced senior leadership in biostatistics and bioinformatics to add scientific value to the CTOT, CTOT-C, and GTCRP clinical trials and observational studies;(2) to provide expertise in biostatistics in the design and analysis of clinical trials and observational studies with significant mechanistic assay objectives designed to illuminate the pathways of autoimmune response in solid organ transplantation;(3) to provide high-quality, integrated, and secure information management systems for the collection of clinical and mechanistic data, the randomization of study subjects, the tracking of specimen collection and distribution, and the reporting of adverse events (AEs);(4) to provide established, standard operating procedures (SOPs) and associated guidelines, templates, and training materials for clinical trial management, site monitoring, data collection, AE reporting, statistical programming, study drug distribution, randomization, and regulatory affairs;and (5) to provide experienced administrative, logistical, and support services for the conduct of consortia Steering Committee (SC) and investigator meetings, as well as DAIT DSMB meetings.
These consortia are funded by NIAID to develop innovative methods for improving long term clinical outcomes in transplant recipients. While short-term outcomes of solid organ transplantation have significantly improved in the last 15 years, this initiative will support the exploration of the mechanisms of acute rejection and graft failure in order to develop biomarker profiles predictive of outcome to improve clinical care.