Clinical Trials Training Symposium

临床试验培训研讨会

• 批准号: 7916131
• 负责人: Katherine A High
• 金额: $ 1.3万
• 依托单位: AMERICAN SOCIETY OF GENE & CELL THERAPY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7916131
• 关键词: Adverse event; American; Cell Therapy; Clinical; Clinical Trials; Clinical Trials Design; Development; Education; Environment; Ethical Issues; Genes; Goals; Grant; Human; Individual; Methods; Oligonucleotides; Request for Applications; Research Personnel; Societies; Therapy Clinical Trials; Training; Translational Research; Viral; Viral Vector; Work; clinical application; cost; gene therapy; gene therapy clinical trial; human subject protection; improved; meetings; novel; public education; public health relevance; research study; response; symposium

DESCRIPTION (provided by applicant): The American Society of Gene & Cell Therapy (ASGCT) was founded in 1996 and is dedicated to the development of gene and cell therapies with a particular focus on professional and public education. In this application we are requesting support for junior investigator and trainee participation in the ASGCT Clinical Trials Training Symposium. This meeting will provide education regarding general issues in clinical trial design and implementation, as well as specific information regarding the conduct of human gene and cell therapy trials. In addition to the education goals, the meeting is meant to improve compliance and promote the protection of human subjects participating in translational research studies. The Proposed R13 grant is requested to provide support for junior investigator and trainee participation in the American Society of Gene & Cell Therapy (ASGCT) Clinical Trial Training Symposium. The society has previously conducted three Clinical Trial Training Symposia in 2001, 2002, and 2003. This was in response to adverse events that occurred in relation to gene therapy clinical trials and was aimed at educating investigators on the regulatory and ethical issues surrounding gene therapy. By 2003, most investigators involved with clinical gene therapy had attended the course. Since 2003, a significant number of individuals have entered the gene and cell therapy field as investigators working with a variety of novel viral vectors, new non-viral methods, oligonucleotide therapy, and inhibitory RNA's, which are being developed for clinical applications. Furthermore, the regulatory environment has changed significantly for both gene and cell therapy. Recognizing these factors, the Society is planning a Symposium in May of 2010. We are requesting $10,000 to reduce the costs for junior investigators and trainees to attend the Symposium. PUBLIC HEALTH RELEVANCE: Since 2003, a significant number of individuals have entered the gene and cell therapy field as investigators working with a variety of novel viral vectors, new non-viral methods, oligonucleotide therapy, and inhibitory RNA's, which are being developed for clinical applications. Furthermore, the regulatory environment has changed significantly for both gene and cell therapy. Recognizing these factors, the Society is planning a Symposium in May of 2010. We are requesting $10,000 to reduce the costs for junior investigators and trainees to attend the Symposium.

描述(由申请人提供)： 美国基因和细胞治疗学会(ASGCT)成立于1996年，致力于基因和细胞治疗的发展，特别关注专业和公共教育。在本申请中，我们请求支持初级研究人员和受训人员参加ASGCT临床试验培训研讨会。这次会议将提供有关临床试验设计和实施的一般问题的教育，以及关于进行人类基因和细胞治疗试验的具体信息。除了教育目标外，会议还旨在改善合规性并促进对参与翻译研究的人类受试者的保护。建议的R13拨款是为了支持初级研究员和受训人员参加美国基因和细胞治疗学会(ASGCT)临床试验培训研讨会。该学会此前曾在2001年、2002年和2003年举办过三次临床试验培训研讨会。这是对与基因治疗临床试验有关的不良事件的反应，目的是教育调查人员有关基因治疗的监管和伦理问题。到2003年，大多数参与临床基因治疗的研究人员都参加了这门课程。自2003年以来，作为研究人员，大量的人进入了基因和细胞治疗领域，研究人员正在开发各种新的病毒载体、新的非病毒方法、寡核苷酸疗法和抑制性RNA，这些正在开发用于临床应用。此外，基因治疗和细胞治疗的调控环境都发生了显著变化。认识到这些因素，协会计划在2010年5月举行一次研讨会。我们要求提供10,000美元，以减少初级调查人员和受训人员参加研讨会的费用。与公共卫生相关：自2003年以来，作为研究人员进入了基因和细胞治疗领域，研究人员致力于各种新的病毒载体、新的非病毒方法、寡核苷酸疗法和抑制性RNA，这些正在开发用于临床应用。此外，基因治疗和细胞治疗的调控环境都发生了显著变化。认识到这些因素，协会计划在2010年5月举行一次研讨会。我们要求提供10,000美元，以减少初级调查人员和受训人员参加研讨会的费用。