Core E Statistics and Clinical Trials will serve as the focal point from which all PPG investigators can draw statistical expertise for the design, data management, and analysis of their research projects. The primary objectives of the Core are to contribute to the science and operation of the overall program by participating fully in its activities, including providing assistance and direction in experimental design, data collection, analysis, modeling, interpretation, as well as data systems, quality control, and statistical data analysis. These services will be utilized in Projects 1 and 2 to generate statistically relevant and meaningful preclinical animal model data to rigorously evaluate our novel immunoconjugates. Core E will also support investigators in carrying out translational/clinical protocols, and the design, conduct, collection, and analysis of the data collected from clinical trials. In addition to providing statistical and clinical support for all Project and other Cores (as needed), Core E will be involved in analysis and presentation of our findings for scientific communications (e.g. publications, conferences, etc.)
The purpose of the Statistics and Clinical Trials Core is to provide centralized statistical and clinical trial design services, as well as collaborative research and data management support for the research projects of the PPG. The core will serve as the focal point from which project leaders, investigators, and other cores can draw statistical expertise for the design, data management and analysis of their research projects. The services provided by Core E are critical to the goal of the PPG by providing innovative statistical approaches, seamless statistical consultation, and database management, in compliance with NIH and FDA regulations.
