Daniel Normolle, PhD, Co-Leader
Somak Roy, MD, Co-Leader
Contemporary translational oncology research requires the integration of bench and clinical science in multi-phase development programs. The bench science data are complex, and data must be analyzed in the clinical and biological contexts of head and neck cancer and capabilities and limitations of the analytic platforms. Core C, the Informatics, Biostatistics and Bioinformatics Core, manages clinical, questionnaire, pathologic, molecular and genomic data in a comprehensive research database and made accessible via a web portal. The Core also provides SPORE investigators with study planning (in vitro, in vivo, in silico, and clinical) and biostatistical and bioinformatic analyses.
Aim 1 (Biostatistics and Bioinformatics): Provide the projects with efficient, unbiased, appropriately powered designs for in vitro, in vivo, in silico, and clinical studies and integrated biostatistical and bioinformatic analyses by statisticians knowledgeable in the science of head and neck cancer, cancer genomics and contemporary high-throughput analytic platforms.
Aim 2 (Informatics): Ensure that in vitro, in vivo, in silico, and clinical data developed by the SPORE are centrally archived, that biosamples are appropriately curated and that data and samples released for analysis in a fashion compliant with federal regulations.
Core C personnel work closely with SPORE investigators, Cores A and B, and Hillman Clinical Protocol and Data Management (CPDM) to ensure that the requisite laboratory and clinical trial data are available for analysis. Core C integrates clinical and laboratory data and controls the distribution of samples as determined by the SPORE Executive Committee (see Core B) via the Organ Specific Database (OSD). A lead statistician is assigned to each SPORE Project, but all Core personnel and the entire Hillman Biostatistics Facility are available for consultation. The biostatisticians perform interim analyses of safety for all SPORE clinical trials, and all Core personnel work with the entire SPORE team in preparing progress reports, abstracts, manuscripts, and presentations. Core C provides experimental designs and data analyses to awardees in the Developmental Research Program (DRP) and Career Development Program (CDP). Core C archives final data and statistical analysis code for all peer-reviewed papers published with the support of the Head and Neck Cancer SPORE.