The Protocol Specific Research (PSR) Shared Resource of the AECCC is designated to facilitate investigator-initiated studies that require intensive data management/research nurse efforts, and which lack other sources of support. Support is requested for two nurse practitioners and two data managers. They will be under the direct supervision of Dr. Scott Wadler and Alicia Destro, Senior Data Manager for the CPDMU, who will assign personnel based on the expected intensity of the study. The PSR core support includes: intensive data management, intensive pharmacokinetic and translational studies, review of complex eligibility requirements, assurance of protocol compliance, review of early stopping rules, interactions with the pharmacy to ensure timely and proper preparation and administration of drug, communication between investigators, and patient and family education. Programs that have utilized the PSR core extensively include gene therapy, biologicals/vaccines, novel therapeutics (including Phase I drug development), bone marrow transplantation, and multidisciplinary Phase II studies. In the 1999-2000 period, there were 14 protocols that utilized the PSR shared resource, with 112 newly enrolled patients. Given the emphasis at the AECCC on translational and multidisciplinary research, and with planned faculty recruitments to expand these programs, this level of utilization will increase substantially over the next five years.
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