SCIENTIFIC REPORT 2004 - Sylvester Comprehensive Cancer Center

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S H A R E D R E S O U R C E S B I O S T A T I S T I C S MANAGER James J. Schlesselman, Ph.D. Professor of Epidemiology and Public Health PURPOSE The division of Biostatistics provides statistical expertise in the study, design, and analysis of data for UM/Sylvester members. Statisticians collaborate on developing protocols for clinical trials, work together on research proposals for laboratory-based investigations, and conduct epidemiological studies. They also perform statistical analyses, interpret results, and author or coauthor papers for publication. Biostatistics is committed to applying statistical and computational methods to improve the way in which clinical trials and translational research are conducted within UM/Sylvester and to developing statistical methodology that aids cancer research. SERVICES Biostatistics provides cancer center members with the following services: 1) Collaboration: Biostatistics seeks to establish enduring collaborations with UM/Sylvester investigators to advance the cancer center’s programmatic research. Such collaborations develop statisticians’ knowledge of specific areas of cancer-related investigation and ensure that statistical considerations are adequately incorporated throughout the course of ongoing research programs. Priority is given to collaborative work, not consulting. 2) Consulting: In contrast to collaborations, which involve long-term collegial relationships in planning studies or analyzing data, statistical consulting generally entails statistical advice or analysis with little involvement in the studies themselves and no co-authorship of publications. Consulting, however, is sometimes a preliminary step to collaborative research where Biostatistics plays a significant role. 3) Study Design: Biostatistics formulates study objectives and endpoints in terms that are appropriate for statistical analysis, recommends alternative study designs, determines the sample size needed to address study objectives at an appropriate level of significance and power, and develops and writes plans for statistical analyses. 4) Data Analysis: After study data have been collected, biostatisticians provide graphical and tabular reports of the results as well as substantive interpretation of the findings. 5) Clinical Trial Applications: Biostatisticians contribute to the design and statistical analysis of investigator-initiated phase I and phase II cancer clinical trials; clinical epidemiology studies; novel diagnostic tests; clinical investigations of cancer therapies; basic science studies of cancer mechanisms; and translational studies of immunologic therapies, chemotherapy-modifying agents, and radio-sensitizing drugs. UM/Sylvester Comprehensive Cancer Center Scientific Report 2004 145
S H A R E D R E S O U R C E S C E L L P U R I F I C A T I O N A N D B A N K I N G F A C I L I T Y MANAGER Kelvin P. Lee, M.D. Associate Professor of Microbiology and Immunology PURPOSE For many UM/Sylvester researchers, the transition from small animal to human studies is prevented by their inability to obtain primary human cells, whether normal or malignant. The overall goal of this facility is to generate purified primary human cells for the cancer research community at the University of Miami. SERVICES Specifically, the services of this facility are to: 1) Provide purified normal primary human hematopoietic cells (T cells, B cells, monocytes, and CD34+ stem cells) for cancer-related research. 2) Bank and provide primary leukemia, lymphoma, and myeloma cell isolates to investigators working with these malignancies. 3) Provide centralized hematopoietic cell isolation, banking, inventory, and database capability for cancer-related clinical trials that are collecting cell samples for research. 146 UM/Sylvester Comprehensive Cancer Center Scientific Report 2004
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SCIENTIFIC REPORT 2004 - Sylvester Comprehensive Cancer Center

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