This core will collaborate and consult with POI Investigators on study design and data analysis to ensure the clinical research will satisfy high scientific standards for statistical rigor. The requested funding will provide statistical support to the clinical trials proposed on Projects 1 &2 and the retrospective studies of clinical outcomes planned in Projects 3 &4, including related data management and computing components. In particular, the Biostatistics Core is a dedicated facility to provide ready and specialized access to: (1) Statistical expertise for the design, planning, and conduct of clinical trials. Design issues may arise in retrospective studies, for example, sample size considerations. (2) Statistical expertise for data analysis, interpretation and reporting of clinical studies. Analysis of clinical trials may include interim monitoring plans for safety and early stopping rules for lack of efficacy. (3) Consultation on developing and implementing plans for (a) data collection, including coding conventions and variable formats (b) data management, including forms design, database specifications and quality control. (4) Consultation on data management plans, including data entry, quality control, study monitoring and protocol auditing. (5) Computing facilities and resources for statistical and related requirements, including data transfer, merging, sharing, and security. The POI projects may require transfer and merging of clinical and laboratory data from different databases, while maintaining patient confidentiality and satisfying federal and institutional standards on personal identifiers. This core supports the mission of the NCI to improve the treatment and continuing care of cancer patients
This research aims to improve radiation treatment for cancer patients by improving our ability to direct the radiation at the tumor to spare adjacent normal tissue by using protons (charged particles) with intensity- modulated proton therapy. This can potentially improve cancer cure rates, reduce side effects, or both, depending on the clinical scenario. With an increasing number of proton centers in the United States and abroad, the research in this program project is increasingly important for public health.