) The Biostatistics Core provides the resource for biostatistical and data management services for the Program Project. These services are divided into the following areas of responsibility. (1) Biostatistical consultation including: providing statistical advice for the design of new studies and analyses for the projects proposed in this through collaboration with each laboratory and clinical investigator on the statistical and scientific aspects of planned protocols, including review and approval of protocols by the biostatistician before submission to the IRB and subsequent activation. (2) Produce randomization tables and establish registration procedures in the Duke Cancer Center Protocol office for randomized clinical trials. (3) Assist with preparation of analyses for seminars, national and international meetings and for publication in scientific journals. (4) Create, collect, maintain and validate databases for the investigational and clinical studies by providing quality controlled data management. (5) Provide programs to collect and transfer data electronically to decrease manual data collection and data entry. This capacity includes the management of the dedicated computer, including computer systems for data storage and access, development of systems improvements, computer space management, computer administration, trouble shooting, collaboration in report development and collaboration in training of data managers, investigators and other personnel; (6) Prepare interim data reports for ongoing clinical studies and to monitor early stopping rules. The Biostatistical Core has an established team in place. Computer and data systems have been developed and are operational for fulfilling the missions described above. The team is composed of a Principal Investigator, Biostatistician and Systems Manager (all experienced in planning and analyzing clinical trials) and a Data Manager Supervisor.
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