The UCLA CLINICAL SCIENTIST TRAINING PROGRAM IN CANCER GENE MEDICINE (K12 CA 76995) has served for six years as a training vehicle for clinical scholars in patient-oriented cancer gene medicine translational and clinical research. This training program has matured significantly in the previous funding period due, in part, to a significant expansion of the cancer efforts in the UCLA Human Gene Medicine Program. To date, 235 patients (91% cancer) have been enrolled in 32 FDA-approved trials using various strategies for the treatment of melanoma, renal and prostate cancer, ovarian carcinoma, CNS tumors, lung cancer and hepatocellular carcinoma. The HGMP subjects all gene medicine trials to multiple overlapping levels of scientific and compliance oversight, and supervises a Level 3 GMP Gene Therapy Core Laboratory. This K12 training grant trains MD fellows in clinical aspects of cancer gene medicine with an emphasis on bridging basic and clinical research, the design and conduct of hypothesis-driven trials, and-in depth didactic training and exposure to institutional and federal regulatory oversight mechanisms and approved processes. This training program has integrated enhanced training in the ethical conduct of cancer gene medicine clinical research. The educational infrastructure has been significantly enhanced to include formal training and certification by the UCLA HGMP/IRB for clinical trials participation, clinical data safety monitoring, mechanisms for submission of IND applications to the FDA and the basic science of gene medicine. In the last funding cycle, this K12 has supported 12 trainees from five oncology disciplines (Medical, Surgical, Thoracic, Urologic and Pediatric) and is represented by seven males (one African-American) and five females. All 12 have remained in acacemic medicine, five have secured tenure-track faculty positions and seven are completing their training. We request support to continue accepting two fellows per year for another five year period.
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