The objective of the projects in this application is to improve the therapeutic results for patients with ALL. The Core? provides the biostatistical collaboration that is essential for the proper design, conduct, analysis and reporting? of the clinical, basic science and translational research studies. 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, follow-up of patients on studies of cardiac function? and design of translational clinical trials. The Core also provides the acquisition of leukemic? specimens which is critical to the success of the basic science components. The? projects that involve translational research objectives 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 specific aims of the Core are: 1) to provide biostatistical collaboration for? basic science, translational and clinical research projects; 2) to provide a Coordinating Center for protocol? management, regulatory reporting, eligibility confirmation, patient registration, sample tracking, and data? management for the collection of individual patient clinical data; 3) to provide Quality Assurance Office for? Clinical 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 facilitate? quality control; 4) to collect research specimens and coordinate patient follow-up at DFCI; 5) to coordinate? the collection of research specimens and follow-up data from consortia centers; 6) to ensure protocol? compliance and accuracy of submitted data from consortia centers by conducting regular on-site data audits of? DFCI and consortia members; 7) to provide computing resources for data processing, report generation, and? statistical analyses; 8) to provide web-based communication for study team and consortia members with? secured access, and a general access website for patient education; 9) to coordinate functions of the Data? Monitoring Committee.?
Showing the most recent 10 out of 214 publications
