) The objective of the Biostatistics Core is to provide statistical and analytical support for members of the University of Colorado Comprehensive Cancer Center (UCCC). The core has been operational since the beginning of the Cancer Center. Over time it has increased its personnel, hours of support and types of services. UCCC members have continuously used core services in research/protocol design, data analysis for clinical trials, and for epidemiologic, prevention, population and basic science studies. During the past year (1999) the core provided 3,200 hours of direct consultation for 44 Cancer Center members in 9 of the 10 Cancer Center programs. The Core personnel reviewed 76 first time protocols and re-reviewed 19 re-submitted protocols. In addition, 854 hours of consultation were devoted to cancer research projects funded by other peer reviewed cancer grants. The services required for clinical trials support has grown considerably with the growth in clinical trial accruals to both therapeutic and control trials. The large increase in the number and size of clinical trials as well as their complexity with increasing amounts of companion basic and translational components created the need for a new centralized informatics relational database. Using NCI supplement funds, institutional funds and some CCSG development funds, the Biostatistics core personnel and the Clinical Investigators Core (CIC) personnel have jointly developed a relational database to support funded clinical and translational trials. The Biostatistics core is responsible for maintenance of the backbone of the system, for confidentiality and limited access, for quality assurance and for upgrading the system. The combined efforts of the CIC and Biostatistics cores has worked with the NCI, CapCure, SWOG, LCBCC, Oracle and CTI to serve as a beta test site for the NCI's efforts to standardize common data elements required for electronic transfer of clinical trial data. The Biostatistics Core will make the outcome of these non CCSG funded efforts available to UCCC members. The rapid development of the genetic/genomics and protomics revolution has created the need for new expertise in """"""""bioinformatics"""""""". Outside recruitments were required to meet the needs to support these types of research using DNA array, mass spectroscopy and other new technologies. One new faculty member has been recruited to meet these needs and another recruitment is in the progress. Core personnel now have expertise in statistical analyses, clinical trials, database management and bioinformatics. The new services should fill the statistical needs of UCCC members for the next grant cycle.
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