Core--Training

核心--培训

• 批准号: 6365392
• 负责人: DAVID A GELLER
• 金额: $ 29.24万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-28 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6365392
• 关键词: biomedical facility; cardiovascular disorder; clinical research; cooperative study; experimental designs; gene therapy; health science research analysis /evaluation; training

The specific aim of this proposal is to provide advanced training to clinician scientists to pursue an academic career in translational research related to cardiovascular gene therapy. Most physicians at the completion of their medical or surgical training do not possess the knowledge or skills needed to implement a basic clinical trial, let alone one utilization gene therapy vectors. Thus, a training program to accomplish these goals must provide exposure to the conduct of a clinical trial, data analysis, medical ethics, and regulatory affairs pertaining to human gene therapy, as well as basic molecular biology skills. We have designed a two-year cardiovascular gene therapy training for two Clinician Scientist trainees per year. We have assembled a diverse group of faculty members that include clinical investigators, molecular biologists, gene therapists, immunologists, pharmacologists, bioengineers, epidemiologists, statisticians, and bioethicists. During the first year, the Clinician Scientist trainees will participate in the NHLBI-funded Clinical Research Training Program (CRTP) established at the University of Pittsburgh. The CRTP aims to teach the skills necessary to design and conduct high quality clinical research. We will utilize the core curriculum and integrated seminar series of the CRTP as part of the training plan to avid unnecessary duplication of resources and allow of immediate implementation. Also, during the first year, each trainee will be assigned to one of the ongoing clinical Cardiovascular Gene Therapy projects to get early exposure to a human gene therapy trial. During the second year, the trainees will participate in the management of active clinical trials through the PCRN and the GCRC. The Pittsburgh Clinical Research Network (PCRN) is a clinical research organization that provides site management services for the conduct of industry-sponsored research. The General Clinical Research Center (GCRC) provides the infrastructure and support staff required for the conduct of clinical research and gene therapy trials at the University of Pittsburgh. The second year of training will also include three Gene Therapy Research Modules with basic coursework and laboratory experience focusing on gene therapy issues. The overall educational goals are to train physicians to conduct clinical gene therapy research related to cardiovascular disease and become competitive in seeking research support for clinical trials. It is expected that each trainee will submit an independent clinical trial proposal within a year of completing the training program.

该提案的具体目的是为临床科学家提供高级培训，以从事与心血管基因治疗相关的转化研究的学术生涯。大多数医生在完成他们的医疗或外科培训时不具备实施基本临床试验所需的知识或技能，更不用说利用基因治疗载体了。因此，实现这些目标的培训计划必须提供与人类基因治疗相关的临床试验，数据分析，医学伦理和法规事务以及基本分子生物学技能的接触。我们设计了一个为期两年的心血管基因治疗培训，每年为两名临床科学家学员。我们已经聚集了一个多元化的教师小组，包括临床研究人员，分子生物学家，基因治疗师，免疫学家，药理学家，生物工程师，流行病学家，统计学家和生物伦理学家。在第一年，临床医生科学家学员将参加在匹兹堡大学建立的NHLBI资助的临床研究培训计划（CRTP）。CRTP旨在教授设计和进行高质量临床研究所需的技能。我们会利用综合培训课程的核心课程和综合研讨会系列，作为培训计划的一部分，以避免不必要的资源重叠，并可即时推行。此外，在第一年，每位学员将被分配到一个正在进行的临床心血管基因治疗项目，以尽早接触人类基因治疗试验。在第二年，学员将通过PCRN和GCRC参与管理正在进行的临床试验。匹兹堡临床研究网络（PCRN）是一个临床研究组织，为行业赞助的研究提供研究中心管理服务。一般临床研究中心（GCRC）提供在匹兹堡大学进行临床研究和基因治疗试验所需的基础设施和支持人员。第二年的培训还将包括三个基因治疗研究模块，重点是基因治疗问题的基本课程和实验室经验。总体教育目标是培养医生进行与心血管疾病相关的临床基因治疗研究，并在寻求临床试验研究支持方面具有竞争力。预计每位学员将在完成培训计划后一年内提交独立的临床试验提案。