This application is to establish the Islet Cell Resources (ICR) Administrative and Bioinformatics Coordinating Center (ABCC) within the Division of Information Sciences at City of Hope National Medical Center. The Principal Investigator (PI) will provide expertise and experience in multi-center study coordination, biomedical informatics, and biostatistics to support the ICR project objectives by carrying out the following specific aims: 1) serving the administrative functions common to the ICRs and coordinating ICR activities that are best housed in a generally accessible single core; 2) providing administrative support and oversight to the ICR Steering Committee and an Information Standards Subcommittee; 3) promoting translational research through the coordination of islet cell distribution, interacting closely with the National Islet and Beta Cell Registry for the efficient exchange of data and facilitation of cell distribution; 4) housing the core informatics resources required to create and maintain the consolidated central database, using innovative leading technology and security and confidentiality practices; and 5) collecting, managing, and analyzing data from the processing of islet cells and from ICR clinical trials, to optimize islet cell isolation and the safety and efficacy of islet cell transplants in humans. Project direction will be provided by a team led by ABCC Director and PI Dr. Joyce Niland, and including Dr. David Ikle, Co-Director for Biostatistics, and Dr. Douglas Stahl, Co-Director for Biomedical Informatics. These investigators have extensive experience managing biostatistics, clinical trials and biomedical informatics resources required to support multi-center clinical trials and basic science investigations. In addition, they will leverage technology for clinical trials data management being developed under the Fully Integrated Research Standards and Technology (FIRST) initiative funded by National Center for Research Resources (NCRR) to provide essential informatics resources to the ten ICR centers participating in this project. The ABCC will work closely with the NCRR and the Steering Committee under a cooperative agreement designed to ensure the safe and efficient development of optimal islet cell transplantation strategies using current Good Manufacturing Practice (cGMP) compliant facilities at each ICR in collaboration with local, regional and national organ procurement organizations and transplant registries. In addition to providing administrative support and informatics infrastructure, the ABCC will monitor ICRs for cGMP and current Good Laboratory Practice (GLP) compliance and will provide expertise in clinical trial design and statistical analysis to facilitate development of clinical trials and to analyze pooled data in the central database to optimize islet cell transplant outcomes.
