The Biostatistics and Computing Core for the Duke SPORE in Breast Cancer is intended to expedite planning and conduct of translational research. This Core will be developed in combination with the Institute of Statistics and Decision Sciences and the Duke Tumor Registry. The Biostatistics and Computing Core will not duplicate existing resources but will enhance Tumor Registry resources for the purposes of this SPORE. Dr. Donald Berry, Professor of the Institute of Statistics and Decision Sciences and statistician for the Cancer and leukemia Group B (CALGB) Breast Cancer Committee, and Dr. Carey Floyd, Associate Professor of Radiology and Biomedical Engineering and is Co-Director of the Duke Tumor Registry, will be managers of this Core. The remaining staff for this Core will include one additional statistician, Constance Cirrincione, who is the staff statistician on the CALGB Breast Cancer Committee. This Core will provide assistance in the statistical aspects of design, conduct, and analysis of basic and clinical scientific studies. Projects involving clinical research will make use of this Core to facilitate efficient clinical trial conduct, proper quality assurance, and timely evaluation and reporting of data. A computerized database using INGRES software will be run on a VAX 4500 with linkage to VT100 terminals or personal computers outfitted with Kermit or Procomm software. A generic set of breast cancer forms has been created, with monthly entry of data into the computerized data base. In addition, individual data entry screens will be developed for specific projects. The data system has automated error checking features, and incorporates standard data security features. Reports on demographics, toxicity, dose intensity, and response can be generated. Data can be transferred into the SAS/stat database for statistical analysis. This Core will also coordinate quality control efforts for the SPORE clinical trials. Monthly clinical trial reports will be circulated to investigators, and will be reviewed at the monthly Core meetings. Six- month summaries of these reports will be reviewed at the biannual review sessions. Annual audits of ongoing clinical trials will be performed by a team consisting of the Core statistician, Dr. Berry, the Principal Investigator of the SPORE, Dr. Iglehart, and one member of the Advisory Board. In addition, this Core will be a resource for the quantitative but non-clinical-trial aspects of the SPORE. This includes aiding in the use of models for assessing the level of genetic susceptibility in Project 3 and assessing the utility of surrogate markers for chemoprevention in Project l.
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