): Early Phase Clinical Research At Norris Cotton Cancer Center (NCCC), early phase clinical research is conducted through both the Early Phase Trials Clinical Oncology Group (EPTCOG) and individual disease-specific Clinical Oncology Groups (COGs). While all clinical investigators are encouraged and able to lead and participate in early phase clinical trials, the overall portfolio and prioritization of early phase clinical trials is managed through the EPTCOG. The EPTCOG is Co-Directed by Drs. Lionel D. Lewis and Marc S. Ernstoff who, with representatives of the research programs, constitute an EPTCOG steering committee. The infrastructure supporting early phase clinical research includes a process for submission and scientific approval of a letter of intent (LOI) for investigator-initiated studies, with provisions for biostatistics, bioinformatics, and correlative studies performed through NCCC Shared Resources. Support for the implementation of the clinical trials of this group is managed through NCCC's Office of Clinical Research, described in the Clinical Protocol and Data Management component of this application. NCCC has a tri-directional network for early translational clinical research involving laboratory and clinical groups as well as involvement in NCI-sponsored national cooperative and network groups (Alliance, NRG and the Cancer Immunotherapy Trials Network [CITN]). Studies utilizing radiobiology agents, devices, surgical approaches, molecular-targeted and immune therapies, and genomic and proteomic profiling are represented in the EPTCOG portfolio, with high-priority given to NCCC investigator- initiated, proof-of-principle, feasibility and Phase I protocols.
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