The Biostatistics and Bioinformatics Core (BABC) provides statistical collaboration and data managementsupport for each of the SPORE projects, the developmental projects, and the other Cores. In addition, theBABC also provides collaboration and support in bioinformatics and computational biology research forSPORE projects as appropriate. In the past funding period the BABC established the infrastructure to link theLymphoma clinical and research databases between Ul and MC. This system is fully functional and allowsweb-based registration and data entry from both sites into a common database. The BABC developed thestatistical plan for the 4 clinical trials (LS0388, LS0382, LS038B, LS058C) initiated in the SPORE as well asthe SPORE imaging trial (LS0383). This core provides data management for each of these trials, monitorsadverse events in collaboration with the Clinical Research Core, and prepares data summaries for manuscriptpreparation. The BABC has been very active in preparing the statistical plan for each of the four Projects inthis competitive renewal. Each of the projects presented in this application reflects input from members of theBABC on study design, analysis plan, and bioinformatics needs. These projects span a wide range ofapproaches and analyses required. The BABC builds upon the innovative and time-tested procedures andsystems developed by Mayo Clinic, one of the largest statistical groups in the country whose members havecollaborated on more than 8,000 clinical and basic science research studies since 1966, as well as theCoordinated Laboratory for Computational Genomics at the University of Iowa founded in 1996. The BABC willprovide statistical and bioinformatics support across different fields, including epidemiological studies, basicsciences including translational and immunologic correlative studies, gene microarray and imaging, clinicaltrials, 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 eachSPORE investigator access to statistical and bioinformatics expertise that includes collaborative developmentof study designs and analysis plans, state of the art data analysis and interpretation, data managementresources, and abstract and manuscript preparation. The BABC also provides a mechanism for themanagement and integration of both existing and newly collected data through consistent and compatible datahandling. Areas of support include database development, data form development and processing, datacollection and entry, data archiving, quality control, and management of information relating to gene mutationidentification and genotyping data for disease linkage experiments. This Core complements and assists theefforts of the Clinical Research and Biospecimens Cores by providing superior data management andexperience with tissue registries. The strengths of the BABC are our collaboration with each of the projectsand cores, the ability to utilize the established centralized research database as well as the operational andstatistical infrastructure already in place in the UI/MC Lymphoma SPORE, and the breadth of expertiseprovided by BABC personnel.
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