Core B: Biostatistics and Data Management

PROJECT SUMMARY/ABSTRACT This Core provides centralized services to the Program Project in four related areas: biostatistics, research computing, data collection, and data management. The biostatisticians collaborate in all phases of research from study design, through interim analysis and monitoring, to final analysis and manuscript preparation. Biostatisticians were co-authors on a breadth of manuscripts funded by this Program Project during the previous funding period and are integral parts of the protocol development and review process. The computing group is responsible for the maintenance and operation of shared computing systems. These include a cluster of Itanium machines that support a centralized patient database, known as Gateway. The computing staff will create and maintain entry and reporting programs for Gateway, assist others in data extraction from the database, and maintain electronic connections to laboratory information which is downloaded directly to Gateway. The data collection group is responsible for data abstraction and entry into Gateway, and for maintenance of archival research files, which are stored in a web-accessible optical image library (OWL). The staff follow an explicit protocol for data abstraction, coding, key entry, and quality control that is applied uniformly to all recipients entering research protocols within the Clinical Research Division, including protocols supported by this program project.