) The purpose of the Biostatistics and Data Operations Core is to enable project investigators to meet their research objectives leading to the understanding of Growth Control of Multiple Myeloma, and ultimately, cure of this malignancy. To these ends, we request support for experienced personnel to build on past progress in developing a highly integrated, multi-disciplinary collaboration among principle investigators, biostatisticians, statistical programmers, and data managers essential to the successful achievement of our aims. The three general components of this core are (1) data collection and management, (2) database development and management, and (3) biostatistical support. The creation of efficiencies via protocol design, standardized toxicity definitions, timing of evaluations and common requisite variable lists across protocols will enable us to refine automation of data management and data collection throughout the progress of clinical protocols. We have developed and will expand the development of flexible, tailored relational databases for specialized sources of patient data while establishing open data base connectivity (ODBC) to institutional data sources already in place. ODBC links among these varied sources of data will provide rapid updating of all pertinent patient data, including automatic updating of SAS databases used in analyses. Biostatistical support provides initial design input for these efforts and conducts appropriate analyses of these efforts, thus, representing the coordinating link among Core components. Based on national guidelines for cooperative clinical trials groups, we justify the need for 2 biostatisticians, 2 statistical programmers, 1 database programmer, 1 data operations/protocol development director, and 7 data managers. Additionally, computer hardware and software is requested to facilitate the biostatistical review of the complex components of this project. Although the Myeloma and Transplant Research Center provides support for a significant portion of this core?s function, additional support through this program project is critical to the successful execution of this project.
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