Biostatistics and Research Support

Dana-Farber Cancer Inst, Boston MA

Investigators

Linked publications & trials

Abstract

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