) The objective of the projects in this application is to improve the therapeutic results for patients with ALL. Acquisition of specimens with leukemic cells is critical to the success of the basic science projects (Projects 6, 7, and 8). The projects that involve translational research objectives (Projects 5, 9 and 10) require access to serial bone marrow and peripheral blood specimens from patients as well as accurate and complete information on the long-term clinical outcomes of these patients. The coordinating center functions provided by this core are essential for the successful conduct of the multi-center clinical trial, the acquisition and distribution of patient specimens, data computerization and quality control, and follow-up of patients on studies of cardiac function, neuropsychological sequelae and quality of life (Project 4). Biostatistical collaboration is also essential for the proper design, conduct, analysis and reporting of the research studies. The purpose of this Biostatistics and Research Support Core is to provide the following services that will be utilized by all of the research projects: 1) to collect research specimens and coordinate patient follow-up at DFCI; 2) to coordinate the collection of research specimens and follow-up data from consortium centers; 3) to ensure that study parameters are followed and confirm eligibility and patient registration; 4) to ensure accuracy of submitted data from consortium institutions (including conduct of on-site audits); 5) to provide biostatistical collaboration for laboratory, translational and clinical research projects (including all aspects of the design, conduct, analysis, and reporting of the studies, and the direction of data processing and data quality control assurance); 6) to provide data management for the collection of individual patient information and data from research laboratories; 7) to provide a biomedical data coordinator to maintain a computerized database, with assured quality control and standardized reporting; 8) to provide computing resources for data processing, forms design and statistical analyses; 9) to provide web-based communication for study team and consortium members with secured access, and maintain an internet web-site for patient education; 10) to coordinate functions of the Data Monitoring Committee.
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