The Biostatistics Core will provide the statistical support for clinical, animal, tissue-based, and cell line investigations in pediatric neuroblastoma supported by this Program Project Grant (PPG). Sound design and statistical input in the planning, conduct, and interpretation of experiments promote the two aspects of translational research: (1) rapid incorporation of significant laboratory findings into the development of data-based therapeutic clinical studies and (2) the development of questions and hypotheses based on clinical findings which can be further investigated in the laboratory. With this in mind, there are three aims of the Biostatistics Core. 1. Provide statistical expertise in the early planning and in the experimental design of laboratory and clinical research a. in vitro experiments (e.g. cell line drug response) b. in vivo experiments (e.g. mouse clinical trials) c. Studies/experiments using specimens from patients (e.g. Affy HuEx) d. NANT Clinical Trials (early phase clinical trials) 2. Provide formal statistical analyses for these experiments and studies 3. Oversee data collection, study progress, data quality control a. With Project 4. oversee the further development and maintenance of the NANT Phase l/ll database.
Statistical collaboration and formal statistical design considerations are essential to the planning of experiments {in vitro and in vivo), clinical trials, and observational studies. Appropriate design is necessary to ensure efficient, feasible studies that will yield meaningful results;appropriate (statistical) analysis, ensures that results are correctly interpreted, and maximizes the information learned.
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