The Biostatistics and Bioinformatics Core (BABC) provides statistical collaboration and data management support for each of the SPORE projects, the developmental projects, and the other Cores. In addition, the BABC also provides collaboration and support in bioinformatics and computational biology research for SPORE projects as appropriate. In the past funding period the BABC established the infrastructure to link the Lymphoma clinical and research databases between Ul and MC. This system is fully functional and allows web-based registration and data entry from both sites into a common database. The BABC developed the statistical plan for the 4 clinical trials (LS0388, LS0382, LS038B, LS058C) initiated in the SPORE as well as the SPORE imaging trial (LS0383). This core provides data management for each of these trials, monitors adverse events in collaboration with the Clinical Research Core, and prepares data summaries for manuscript preparation. The BABC has been very active in preparing the statistical plan for each of the four Projects in this competitive renewal. Each of the projects presented in this application reflects input from members of the BABC on study design, analysis plan, and bioinformatics needs. These projects span a wide range of approaches and analyses required. The BABC builds upon the innovative and time-tested procedures and systems developed by Mayo Clinic, one of the largest statistical groups in the country whose members have collaborated on more than 8,000 clinical and basic science research studies since 1966, as well as the Coordinated Laboratory for Computational Genomics at the University of Iowa founded in 1996. The BABC will provide statistical and bioinformatics support across different fields, including epidemiological studies, basic sciences including translational and immunologic correlative studies, gene microarray and imaging, clinical trials, and gene and mutation discovery, expression analysis and genomics, and information management. The comprehensive nature of the BABC, which will have activities at both the MC and Ul, assures each SPORE investigator access to statistical and bioinformatics expertise that includes collaborative development of study designs and analysis plans, state of the art data analysis and interpretation, data management resources, and abstract and manuscript preparation. The BABC also provides a mechanism for the management and integration of both existing and newly collected data through consistent and compatible data handling. Areas of support include database development, data form development and processing, data collection and entry, data archiving, quality control, and management of information relating to gene mutation identification and genotyping data for disease linkage experiments. This Core complements and assists the efforts of the Clinical Research and Biospecimens Cores by providing superior data management and experience with tissue registries. The strengths of the BABC are our collaboration with each of the projects and cores, the ability to utilize the established centralized research database as well as the operational and statistical infrastructure already in place in the UI/MC Lymphoma SPORE, and the breadth of expertise provided by BABC personnel.
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