The Clinical Trials Office (CTO) Shared Resource has as its mission the support of clinical trials by Yale Cancer Center members. This Shared Resource, coupled with the staff of the Protocol Specific Research Support (PSRS) Shared Resource [also referred to as the Clinical Trials Institutional Research Core (CTIRC)] and the Clinical Protocol Review and Monitoring System (CPRMS) Shared Resource, provides the nursing, data management, protocol development expertise, regulatory guidance and patient access needed to successfully conduct Phase I, II and III studies. The long term goal of this Shared Resource is to make it possible for Yale investigators to conduct innovative trials rapidly, in accord with good clinical practice guidelines, with accurate data collection and data available on line in a user friendly data base. This data base has been creative in collaboration with the Center for Medical Informatics and has been adopted by the Medical School as the standard for clinical trials in all area. In the past two years a new clinical trials programs has been added, the Yale Oncology Network (YON), under the direction of the Associate Director for Clinical Trials. YON represents a consortium of hospitals and practices in the State of Connecticut whose purpose is to conduct state of the art clinical trials in the community setting. The CTO plays a critical role in the functionality of the YON by providing administrative and technical support. The focus of this Shared Resource will be Phase I and II studies, especially those which evaluate critical scientific hypotheses, evaluate novel therapies and test promising new agents up through and including studies of proof of concept. The program will continue to evaluate traditional cytotoxics, biologicals as well as new classes of agents.
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