Cancer Prevention Clinical Trials Monitoring and Informatics Support

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The National Cancer Institute Division of Cancer Prevention (NCI DCP) supports science that seeks not only to identify those at high risk of developing cancer, but also to identify and develop chemopreventive and other interventions that will inhibit, regress, reverse, prevent or delay the incidence of cancer. NCI DCP manages a portfolio of scientific and clinical activities which includes identifying and prioritizing agents with potential cancer prevention activity, selecting agents for development, performing pre-clinical studies, conducting Phase I and Phase II trials for testing agents, and moving promising agents into larger Phase III cancer prevention clinical trials. These cancer prevention trials are conducted by extramural investigators at national and international clinical sites. As sponsor of a trial, NCI DCP is responsible for ensuring that clinical trials are conducted safely and according to protocol from the initial safety studies through the definitive evaluation of the role of the new agent or intervention in the prevention of specific types of cancer. Fulfillment of this responsibility requires careful and thorough monitoring of a clinical trial throughout its entire process including the verification of clinical trials data as well as investigator compliance with the protocol, Good Clinical Practice Guidelines and applicable regulatory requirements and clinical trials policies. The Cancer Prevention Clinical Trials Monitoring and Informatics Support contract provides comprehensive clinical trial oversight capability for the Phase 0, Phase I, Phase II, and selected Phase III cancer prevention clinical trials sponsored by NCI DCP.