UCLA Clinical Scientist Training in Cancer Gene Medicine

描述(由申请者提供)：加州大学洛杉矶分校癌症基因医学临床科学家培训计划(K12 CA 76995)已为面向患者的癌症基因医学翻译和临床研究的临床学者提供了六年的培训工具。由于加州大学洛杉矶分校人类基因医学计划中癌症工作的显著扩展，这一培训计划在前一资助时期已显著成熟。到目前为止，已有235名患者(91%的癌症)参加了FDA批准的32项试验，使用各种策略治疗黑色素瘤、肾癌和前列腺癌、卵巢癌、中枢神经系统肿瘤、肺癌和肝细胞癌。HGMP将所有基因药物试验置于多个重叠级别的科学和合规监督之下，并监督一个3级GMP基因治疗核心实验室。 这项K12培训基金在癌症基因药物的临床方面培训MD研究员，重点是连接基础和临床研究、假说驱动试验的设计和实施，以及深入的教学培训和接触机构和联邦监管监督机制和批准的程序。这一培训计划整合了癌症基因药物临床研究伦理行为方面的强化培训。教育基础设施已得到显著加强，包括由加州大学洛杉矶分校HGMP/IRB提供的关于参与临床试验、临床数据安全监测、向FDA提交IND申请的机制以及基因医学基础科学的正式培训和认证。 在上一个供资周期中，K12资助了来自五个肿瘤学学科(内科、外科、胸科、泌尿科和儿科)的12名受训人员，其中有7名男性(1名非裔美国人)和5名女性。所有12人都仍在贫血医学领域，5人已获得终身教职，7人正在完成培训。我们请求提供支助，以便在今后五年期间继续每年接收两名研究员。

DESCRIPTION (provided by applicant): 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.