UCLA Clinical Scientist Training in Cancer Gene Medicine

加州大学洛杉矶分校癌症基因医学临床科学家培训

• 批准号: 7116526
• 负责人: James S. Economou
• 金额: $ 50.87万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7116526
• 关键词: clinical research; clinical trials; continuing education; data collection methodology /evaluation; ethics; experimental designs; gene therapy; health science research support; human subject; informed consent; medical education; meeting /conference /symposium; molecular genetics; neoplasm /cancer education; neoplasm /cancer genetics; neoplasm /cancer pharmacology; neoplasm /cancer therapy; pharmacogenetics; physicians; training; workshop

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.

描述（由申请人提供）：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) 已作为临床学者以患者为导向的癌症基因医学转化和临床研究的培训工具服务了六年。 该培训计划在上一个资助期间已显着成熟，部分原因是加州大学洛杉矶分校人类基因医学计划的癌症工作显着扩大。 迄今为止，已有 235 名患者（91% 患有癌症）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 使所有基因医学试验都受到多重重叠的科学和合规监督，并监督 3 级 GMP 基因治疗核心实验室。 这项 K12 培训补助金对医学博士研究员进行癌症基因医学临床方面的培训，重点是衔接基础研究和临床研究、假设驱动试验的设计和进行、深入的教学培训以及机构和联邦监管监督机制的接触和培训。批准的流程。 该培训计划整合了癌症基因医学临床研究道德行为方面的强化培训。 教育基础设施得到了显着增强，包括加州大学洛杉矶分校 HGMP/IRB 的正式培训和认证，涉及临床试验参与、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。 在上一个资助周期中，该 K12 已为来自 5 个肿瘤学学科（内科、外科、胸科、泌尿科和儿科）的 12 名学员提供了支持，其中包括 7 名男性（1 名非裔美国人）和 5 名女性。 所有 12 人都留在了学术医学领域，其中 5 人已获得终身教职，7 人正在完成培训。 我们请求支持，以便在接下来的五年内继续每年接受两名研究员。