The goal of this application is to provide support for scientific leadership and clinical trial infrastructure within the Duke Cancer Institute in the development and conduct of clinical trials as part of the National Clinical Trials Network (NCTN). The studies will concentrate on definitive, randomized, late Phase clinical treatment and advanced imaging trials in oncology in association with multiple adult Network Groups. The award will further Duke's continued substantial accrual to clinical trials funded by the NCI, and specifically trials conducted across the entire National Clinical Trials Network (NCTN) as part of NCI's overall clinical research program for adults and children with cancer. An important focus will be an emphasis on trials in special populations, including under-served populations and rare tumors. The leadership of the 5 Principal Investigators named in the grant application, along with the faculty of the 9 NCI approved research programs at Duke and the Duke Central Cooperative Group Office will provide a strong and efficient backbone for NCTN clinical research scientific leadership and patient enrollment effort. Our continued participation as a member of the Alliance (formerly CALGB, ACOSOG and NCCTG), GOG, NSABP and RTOG (soon to be NRG), ACRIN (now ECOG-ACRIN) and enrollment in trials offered by all current adult NCI funded Cooperative Groups through the CTSU mechanism, gives Duke the experience and knowledge needed to lead and enroll in complex NCI funded research involving multiple cancers sites and treatment modalities. The definitive evaluation of newly developed therapies for cancer care including multi-modality treatments, combinations of novel agents, and molecularly-based treatment and advanced imaging approaches, will benefit patients and practitioners as well as the entire oncology research community. This grant will also help to foster an ideal environment to enhance multidisciplinary collaborations and develop the next generation of clinical investigators dedicated to cancer research. The support provided to Duke as a lead academic site will be leveraged against the significant scientific and clinical resources of the Duke Cancer Institute to provide robust participation in a nationally established clinical trial program.
Participation of patients and investigators in NCTN clinical trials is vital to our understanding of the biology and treatment of cancer. Support of NCTN leadership activities of Duke Faculty and clinical research staff effort will help us maintain our high patient enrollment and robust scientific participation in clinical trials of national importane.