The objective of this proposal is to develop the Operations, Biostatistics and Data Management Center (OBDMC) and infrastructure to support the Pediatric Brain Tumor Clinical Trials Consortium (PBTCTC) for the expeditious evaluation of new therapeutic approaches in children with central nervous system (CNS) tumors. The Consortium of eight Participant Member Institutions is expected to recruit 80-100 patients each year to 3-4 clinical trials. The primary objective of the Consortium is to improve the therapeutic outcome for children with CNS tumors through the conduct of phase I, II and pilot clinical trials and preliminary correlative laboratory investigations. The trials will evaluate innovative and technically challenging therapies and diagnostic procedures. The role of the Operations, Statistics and Data Management Center in achieving this objective includes: 1. Coordinating protocol development and management including amendments and status changes (opening, suspension, closures, etc.) And circulating protocols and amendments to Participant Member Institutions and the NCI. 2. Providing sound statistical science to the Consortium for the design and analysis of clinical trials and for the timely reporting of findings. 3. Designing and developing a distributed data management (DDM) system to ensure accurate and timely acquisition of study data consistent with study designs and objectives while providing a secure system for the electronic collection and storage of Consortium information. The following subsidiary tasks will be performed: 4. Implementing procedures to meet all regulatory reporting requirements. 5. Administering laboratory correlative studies, including coordination and support for the acquisition and shipping of specimens and data; as well as coordination and tracking of banked tissue in a virtual brain tumor tissue bank.
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