EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-030) ABSTRACT The Early Phase Clinical Research Support (EPCRS) component provides data management support to conduct novel early-phase clinical trials designed from research findings of UCCC members. The overall objective of the EPCRS is to promote innovative clinical trials in the UCCC catchment area (the State of Colorado), to facilitate inter- and intra-programmatic translational collaboration within UCCC, and to support the development of novel cutting-edge therapies and strategies to prevent and treat cancer. These clinical trials are hypothesis-driven, high-priority, innovative, Pilot (feasibility) or Phase 0/I institutional trials focused on early phase testing of an agent or device for the diagnosis, prevention, detection or treatment of cancer. Expected outcomes include subsequent later stage clinical testing through the National Clinical Trials Network (NCTN), the Phase II mechanism of the Experimental Therapeutics Clinical Trials Network (ET-CTN), or in conjunction with independent peer-reviewed grant support or industry funding. Although EPCRS was not funded over the last cycle due to disapproval of our PRMS, UCCC has continued to conduct early phase trials which adhere to the NCI eligibility requirements of this mechanism and through our NCI UM1 Southwest Early Clinical Trials (SECT) Consortium (UM1CA186688) with MD Anderson Cancer Center, as well as institutional and industry support, funding has been available to translate bench observations made by our translational UCCC members, to the bedside. Going forward a number of changes have been instituted to further ensure that only the highest quality early clinical science is carried out at UCCC. These include an Investigator-Initiated Trial (IIT) structure, that includes an IIT Incubator (IIT-I) meeting chaired by Eckhardt that brings together a multidisciplinary group of investigators to discuss and promote hypothesis-driven early trials, as well as an IIT Review Committee (IIT-RC) chaired by Flaig and Eckhardt that is charged with ensuring that all components of a concept such as the scientific rationale, statistics, data management, budgeting and finance are assembled to enhance feasibility and to enable prioritization for funding decisions. In addition to the requested CCSG funds, UCCC will provide $250K/yr for early-phase clinical trials that will facilitate expansion of IITs and provide greater opportunity for the translational science of UCCC programs to impact patients in our catchment area. Our future directions include: 1) Establishing processes that stimulate direct collaborations between the UCCC clinical disease groups and the UCCC Research Programs; 2) Working with preclinical scientists in the UCCC to enable the development of novel animal models that can be used provide the rationale for hypothesis-driven early clinical trials; 3) Evaluating challenges regarding participation among racial/ethnic and socioeconomically underserved populations in early clinical trials; 4) Interacting with major UCCC wide strategic initiatives that involve early clinical investigation.
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