Clinical Trials Methods Workshop - Europe

描述（由申请人提供）：要求提供资金，以支持一个题为：“临床试验方法研讨会-欧洲。“这个工作坊的具体目标是：（1）培训一批年轻的临床研究人员，使他们掌握设计和进行临床试验的方法;（2）通过确定继续从事以病人为中心的研究并达到工作坊其他目标（例如，完成其协议等）。 本研讨会将提供给年轻的肿瘤学家（来自肿瘤学的任何学科）谁是刚刚完成他们的培训（约。 75%的学生）或最近开始他们的初始教师职位（约。 25%的学生）。 不幸的是，任何博士后项目通常都不提供设计和进行癌症临床试验的培训。 在这一领域培训年轻的肿瘤学家应该有助于确保新的治疗或预防药物在临床上以尽可能合理和快速的方式进行测试。 拟议的讲习班将由美国妇女协会组织和举办。 癌症研究（AACR），欧洲癌症协会联合会（FECS）和美国临床肿瘤学会（ASCO）。 这个研讨会是基于一个类似的，非常成功的研讨会已在韦尔，科罗拉多，并资助了国家癌症研究所（NCI）在过去的7年。 拟议的讲习班将在欧洲举行，原因是：（a）第二次单独的讲习班将使来自欧洲的更多高素质、积极性高的年轻临床研究人员得到培训，而不会削弱美国维尔讲习班的努力;（B）通常申请参加维尔讲习班的欧洲学生不必长途跋涉，从而减少旅费;（c）它有助于利用欧洲经验丰富的优秀临床研究人员作为讲习班的教师;（d）它允许美国研究人员骨干，他们将帮助在欧洲教授讲习班，深入了解欧洲正在研究的临床试验方法和新药剂，可能使这些方法和药剂能够在美国更快地进行测试（例如，奥沙利铂）;（e）可使国家癌症研究所在欧洲进行的临床前工作的投资获得最大的回报;及（f）可培养更多背景更多元化的临床研究人员，以研究癌症治疗和预防问题。 严格的标准是在地方选择学生的工作坊。 一个由经验丰富的临床研究人员和教师（榜样）组成的优秀团队已经聚集在一起，在一个最大限度地提高学生和他们的教师导师之间联系的环境中教授讲习班。 有几个创新的教学技术在讲习班中使用，包括要求学生完成协议概念表和完整的协议在讲习班结束前。 这是在有成就的临床试验者和生物统计学、伦理学和其他肿瘤学专业专家的密切监督下完成的。 最后，已经建立了一个行之有效的评价系统，以证明讲习班将实现其目标。

DESCRIPTION (provided by applicant): Funding is requested to support a workshop entitled: "Clinical Trials Methods Workshop - Europe." The specific aims of this workshop are: (1) To train a group of young clinical investigators in methods in design and conduct of clinical trials; and (2) to evaluate the graduates of the Workshop by determining the percentage who stay in patient-oriented research and meet the other objectives of the Workshop (e.g., complete their protocols, etc.). This Workshop will be offered to young oncologists (from any discipline of oncology) who are just completing their training (approx. 75% of the students) or have recently begun their initial faculty positions (approx. 25% of the students). Training in the design and conduct of cancer clinical trials is, unfortunately, not usually provided in any postdoctoral programs. Training young oncologists in this area should help assure that new therapeutic or prevention agents are tested in the clinic in as sound and as rapid a manner as possible. The proposed Workshop will be organized and conducted by the American Association for Cancer Research (AACR), the Federation of European Cancer Societies (FECS), and the American Society of Clinical Oncology (ASCO). This Workshop is based on a similar, highly successful Workshop which has been conducted in Vail, Colorado, and funded by the National Cancer Institute (NCI) for the past 7 years. The proposed Workshop will be held in Europe because: (a) a second, separate Workshop would enable additional, highly qualified, highly motivated, young clinical investigators from Europe to be trained without diluting the efforts of the Vail Workshop in the United States; (b) students from Europe who would normally apply to the Vail Workshop would not have to travel great distances, thus reducing travel expenses; (c) it facilitates utilization of excellent experienced clinical investigators in Europe as teachers for the Workshop; (d) it allows a cadre of U.S. investigators, who will help teach the Workshop in Europe, gain insight into clinical trial methods and new agents that are being investigated in Europe, potentially enabling those methods and agents to be tested more quickly in the U.S. (e.g., oxaliplatin); (e) it maximizes the return on the investment of the NCI in preclinical work in Europe; and (f) it will produce more clinical investigators with more varied backgrounds to bear on the cancer treatment and the cancer prevention problems. Stringent criteria are in place to select students for the Workshop. An outstanding group of experienced clinical investigators and teachers (role models) has been assembled to teach the Workshop in a setting that maximizes contact between students and their teacher mentors. There are several innovative teaching techniques utilized in the Workshop, including the requirement that the students complete both a protocol concept sheet and a complete protocol before the end of the Workshop. This is done under intensive supervision by accomplished clinical trialists and experts in biostatistics, ethics, and other oncologic specialties. And, finally, a proven evaluation system is in place to demonstrate that the Workshop will meet its objectives.