) The role of the Biostatistics Core is to provide statistical expertise and data management support to the Program Project, and to integrate the two components to facilitate the interdisciplinary nature of the broad research goals. The discipline of biostatistics encompasses the design, conduct, and analysis and interpretation of research study outcomes. Initially, the biostatistical role is to ensure that the study design and the scientific questions posed are mutually compatible. Determination of the data elements required for the study, construction of a schedule for their collection, and the manner in which they are derived and coded are important practical ingredients in ensuring that the resulting data will be amendable to valid statistical analysis. The Biostatistics Core has a major role in ensuring that the study is conducted in accordance with the planned design, including ongoing quality control of the data. Finally, the biostatisticians are responsible for performing statistical analysis of the data, drawing pertinent statistical inferences from the analysis, and providing substantive interpretations in the context of the results of related published articles.
The specific aims of the Biostatistics Core are as follows: 1) The core will provide an integrated database of all ovarian cancer patients seen on the Gynecology Service during the study period. Such a database will encompass information on clinical outcomes, laboratory tests, pathology, treatment, and follow-up for these patients. Existing databases will be transferred to be integrated database. 2) The core will provide statistical support for all Projects through collaboration with the investigators. Statisticians will participate in the design of all studies to ensure that research questions are appropriately quantified and answerable with adequate statistical power, they will perform the technical analyses, participate in the interpretations of results, and contribute to the writing of the scientific report.
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