The objective of the projects in this application is to improve the therapeutic results for patients with ALL. The Coreprovides the biostatistical collaboration that is essential for the proper design, conduct, analysis and reportingof the clinical, basic science and translational research studies. The coordinating center functions provided by thisCore are essential for the successful conduct of the multi-center clinical trial, the acquisition and distribution ofpatient specimens, data computerization and quality control, follow-up of patients on studies of cardiac functionand design of translational clinical trials. The Core also provides the acquisition of leukemicspecimens which is critical to the success of the basic science components. Theprojects that involve translational research objectives require access to serial bone marrowand peripheral blood specimens from patients as well as accurate and complete information on the long-termclinical outcomes of these patients.
The specific aims of the Core are: 1) to provide biostatistical collaboration forbasic science, translational and clinical research projects; 2) to provide a Coordinating Center for protocolmanagement, regulatory reporting, eligibility confirmation, patient registration, sample tracking, and datamanagement for the collection of individual patient clinical data; 3) to provide Quality Assurance Office forClinical Trials (QACT) collaboration to develop and maintain computerized databases, design CRFs,computerize both clinical and research laboratory data and provide reports and data requests to facilitatequality control; 4) to collect research specimens and coordinate patient follow-up at DFCI; 5) to coordinatethe collection of research specimens and follow-up data from consortia centers; 6) to ensure protocolcompliance and accuracy of submitted data from consortia centers by conducting regular on-site data audits ofDFCI and consortia members; 7) to provide computing resources for data processing, report generation, andstatistical analyses; 8) to provide web-based communication for study team and consortia members withsecured access, and a general access website for patient education; 9) to coordinate functions of the DataMonitoring Committee.
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