CORE--BIOSTATISTICS

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DESCRIPTION: (Applicant's Description) The Core is responsible for biostatistical design and analysis of clinical trials supported by this program project grant; to develop and maintain database containing the data of the project with a build in system to assure quality control of the data gathered. The data are maintained in the institutional clinical research database. This database allows realtime data transfer and immediate patient eligibility verification, which is a considerable asset and strength for this program. The core is organized by disease topic with assignment of statisticians to a specific disease enabling them to become thoroughly familiar with the disease entity they work in. The statisticians are intimately involved with the clinical trials, as they attend "their-disease" oriented research conferences, contributing to the initial design of the trials and design of the biostatistics section of the protocols, including sample size projection, study design and analysis. The Biostatistical Core provides state of the art statistical methods applicable to medium sized studies in which it will be possible to abandon studies early because of toxicity or lack of efficacy, to "conserve" on patients and resources, and to enhance safety. All phase II and the small number of phase III studies are well designed indicating that the core is very familiar with the literature therefore enabling them to institute novel methods early.