The Clinical and Experimental Therapeutics Program (Program 4) is a cohesive, integrated programsupported by $7,523,204 (annual direct costs) in peer-reviewed funding, with $3,613,675 from the NCI.There are 47 members representing nine departments. Of the total 747 member peer-reviewed publicationsduring the current grant cycle, 216 (29%) represent intraprogrammatic, and 145 (19%) representinterprogrammatic collaborations.The overall goal of the Program is to foster interaction between basic and clinical investigators that will resultin innovative and effective therapies for cancer patients. The translational nature of much of the workemanating from this program and the leadership role assumed by many program faculty in studiesconducted by national clinical trials cooperative groups illustrates the impact of this program in developingnew therapies for oncology. The Program has a long-standing focus on drug development at all phases ofclinical testing and a strong pharmacogenetic component. Trials span the gamut from preclinicaldevelopment to investigator-initiated Phase I clinical trials, to Phase II trials in the regional Phase II networkto Phase III studies within CALGB. They incorporate correlative laboratory studies including pharmacokineticstudies, genotyping studies, population pharmacology, pharmacogenetic studies, and the measurement ofsurrogate endpoints. Clinical trials are conducted by multidisciplinary teams comprised of a group of clinicalinvestigators representing Medical Oncology, Radiation Oncology, Pathology, and appropriate surgicalspecialties. Clinical efforts focus on studies of new drugs (cytotoxic or cytostatic) with clinical andtranslational endpoints, modulation of current chemotherapy, sequencing of multidisciplinary treatment,organ preservation, transplantation, and treatment intensification as strategies to increase cure rates andresponse. Imaging, surgical, and pathology support are integrated into the Program.The scientific goals are (1) to foster interaction between basic and clinical investigators that will result ininnovative and effective therapies; (2) to integrate new drugs into the development of multimodalitytherapies for patients with advanced solid tumors; and (3) to pursue a broad program of preclinical,translational, and clinical research in pharmacogenetics and pharmacology.
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