For more than 40 years, the NCI has supported a clinical trials infrastructure program to conduct early-phase clinical trials across the US. The NC created the NCI Experimental Therapeutics Program (NExT), which represents a joint early therapeutics development program between NCI intramural and extramural teams/institutions to prioritize a pipeline of NCI-driven targeted therapeutics. The NCI has now developed a comprehensive plan to transform the NCI-sponsored experimental therapeutics clinical trials program from a series of separate institutions conducting early-phase cancer treatment trials to a new consolidated, integrated Program, referred to as the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). The University of Pittsburgh Cancer Institute (UPCI) has been an NCI-designated comprehensive cancer center since 1990, and the UPCI has been involved in the NCI-U01 Phase 1 Early Drug Development Program since 1999. In March 2013, UPCI was awarded an NCI UM1 Phase 1 grant as a Lead Academic Organization (LAO) within the newly configured NCI ETCTN, and our group in Pittsburgh is one of only 12 such LAO centers in the U.S. We now plan to expand the scope of our early phase clinical trial activities by including capabilities to conduct Phase 2 clinical trials. We have established the Pennsylvania Cancer Consortium (PCC), which represents a collaborative effort between UPCI and the University of Pennsylvania Abramson Cancer Center (ACC), the two largest NCI-designated comprehensive cancer centers in the State of Pennsylvania. The goal of the PCC is to create a unified, integrated clinical trials network across the entire State of Pennsylvania that will provie the efficient and comprehensive conduct of early phase clinical trials. This integration of Phase 2 capabilities in the PCC will allow for more seamless advancement and progress of novel experimental agents and/or combination regimens through early stages of drug development. The eventual goal of our program is to greatly facilitate and accelerate the delivery of new cancer therapies to the citizens of the State of Pennsylvania and in bordering states, including Ohio, West Virginia, New York, New Jersey, and Delaware.
As a Lead Academic Organization of the NCI ETCTN, the UPCI plans to leverage its significant experience and leadership in early-phase clinical drug development and facilitate the early-phase clinical development of novel therapeutic agents and combinations that are of high priority to the NCI and the national interest. The long-term goal of this effort is guide future disease-specific clinical trials in the phase 2 setting that may have te potential to change the standard of cancer care in the US and worldwide.
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