Shared Resources-Clinical Research Services

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The Biostatistics Shared Resource provides support for the three broad major programmatic areas of YCC: clinical science; basic science; and population science. The services provided include: biostatistical support to research projects, assistance with the statistical and research aspects of new research projects and grant applications, data analysis, and training/As such, this core is vital to clinical trials/study design process. Additionally, this core has the major responsibility to support the protocol review and monitoring process of the YCC. Thus, this Shared Resource provides critical support for the complete spectrum of statistical services, from study design through the final research report writing. In late 2005, Dr. Theodore Holford accepted the position as Director of this core facility. Dr. Holford will work closely with Dr. Daniel Zelterman, who serves as Co-Director of the Biostatistics Shared Resource. The Biostatistics Shared Resource is Cancer Center Managed and provides statistical support and data analysis to YCC in the form of active consultation with six Ph.D. statisticians dedicated to the YCC. The 2 major criticisms of the previous renewal have been addressed. Specifically, creation of a Biostatistics Clinical Studies Group, chaired by Dr. Holford, ensures that biostatistical expertise applied to Protocol Review Committee evaluation of prospective clinical trials will be completely distinct from that involved in the particular study's design and subsequent analysis of accrued data. In addition, the biostatistical staff has been significantly expanded, to provide full coverage for the marked increase in investigator-initiated clinical research activities, resulting from the recruitment of a large number of new clinical researchers. Over the past 2 years, 11 new investigative clinical oncologists have joined the YCC, and their clinical trials efforts have led to a 56% increase in the required biostatistical support. In order to support these increased needs, the faculty biostatistician staff of this Shared Resource has grown from 2 to 7. In this renewal application, we are requesting 1.75 FTE for the next period of funding. In 2005 100%, or 42, users were YCC members (65.5% Peer reviewed) from all 8 of the YCC research programs