The use of modern statistical methods, analytic techniques, data processing and database design is necessary in translational research in neuroblastoma (NB). The Biostatistics Core of this program project (PPG), which comprises biostatistical experts in clinical and translational study design and analysis, Dr. Susan Groshen (Core Director), Dr. Richard Sposto, and Dr. Yimei Li, and an experienced staff, will play the central role in fulfilling this requirement. The primary responsibility of the Biostatistics Core is to ensure that appropriate and efficient statistical designs and analyses are employed in the research. To this end, members of the Biostatistics Core will involve themselves in the design of laboratory experiments and clinical studies conducted during this program project. The Core will identify, adapt, or develop appropriate statistical design and analysis methods, will analyze data, produce coherent and complete reports of the results of these analyzes, and co-author papers reporting these results. In addition, the Biostatistics Core, collaborating with Core B, will play an important role in developing and conducting clinical trials undertaken based on the results of Projects 1 through 5, monitoring the safety of patients enrolled on these trials, and ensuring the quality and integrity of the data collected from these trials. Core C is essential to the overall success of the translational mandate of this Program.
Statistical collaboration and formal statistical design considerations are essential to the planning of laboratory experiments, clinical trials, and observational studies. Appropriate design is necessary to ensure efficient, feasible studies that will yield meaningful, robust and reproducible results; appropriate (statistical) analysis, ensures that results are correctly interpreted, and maximizes the information learned. To this end, members of the Biostatistics Core C will involve themselves in the design and analysis of the laboratory experiments and clinical studies conducted in all 5 projects of this program to support the translational research directed towards substantively improving the outcome of patients with high-risk neuroblastoma.
