This application is submitted in order for the University of Florida, Department of Statistics with assistance from the Department of Health Policy and Epidemiology, to continue its role of Statistical Office, Pediatric Oncology Group (POG). In this role, we plan to collaborate with our clinical colleagues and clinical research associates (CRAs) at the POG institutions in protocol development, clinical trial design, correlative laboratory studies, data management, safety monitoring, quality assurance, and publication of results. Our objectives for the next five years include (a) to expand protocol coverage to accrue 2800 therapeutic patients per year by 1996; (b)to provide remote data entry by POG institutions by January, 1997; (c) to continue to provide improved groupwide communication via the POG Electronic Bulletin Board System (BBS); (d) to continue to work toward pragmatic minimal data requirements, to ensure efficient operation; (e) to continue to contribute to statistical methods relevant to pediatrics trials; (f) to collaborate with the Children's Cancer Group (CCG) on intergroup studies where POG patient resources are insufficient on their own; and (g) develop electronic storage for filing protocols, correspondence, and patient records to reduce our paper load. The major emphasis of our research is to conduct randomized Phase III trials aimed at improving the cure rates for children, and to identify children at especially high risk for failure. By the use of Phase I, Phase II, and Pilot studies, new therapeutic strategies can be assessed for possible inclusion in later Phase In trials. Statistical Office design, monitoring, and analysis play an integral part of the process. The Statistical office, clinical study coordinators, and Operations Office work closely together, along with the Clinical Trials Monitoring Branch, to assess compliance and institutional performance.
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