Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (NIA/AA IMPACT-AD) Course

项目摘要 自从FDA最近一次批准一种治疗阿尔茨海默病和相关疾病的新方法以来， 痴呆症（ADRD）。对改善现有疗法和遏制公共卫生影响的使命至关重要 ADRD将是新一代ADRD科学家，特别是具有独特培训和技能的科学家 设计和执行临床试验所必需的。这种培训很少通过传统课程提供， 医学或生物统计学教育。因此，缺乏训练有素的ADRD临床试验人员。此外，委员会认为， 目前活跃的ADRD试验研究者群体的多样性非常有限。开发改进的 治疗ADRD，临床试验中的多学科专业知识将是必要的，包括医学专家 还包括生物统计学、试验设计、生物标志物、伦理学和信息学方面的专业知识。这一提议要求得到支持 在ADRD试验的基本要素方面建立首个同类培训计划。方法研究所 和ADRD临床试验推进方案（IMPACT-AD）课程将充分利用 阿尔茨海默氏症临床试验联盟（ACTC）附属教师的基础设施和专业知识。IMPACT-AD 将每年进行一次，以吸引和培训下一代ADRD临床试验者，特别关注 提高ADRD临床研究者在种族/民族、性别和科学/专业方面的多样性 背景IMPACT-AD旨在为各种临床医生、科学家和研究人员提供 ADRD临床试验设计和实施方面的现代化和强大的培训。

Project Summary It has been nearly 15 years since the last FDA approval for a new treatment for Alzheimer's Disease and Related Dementias (ADRD). Critical to the mission to improve the available therapies and curb the public health impact of ADRD will be a new generation of ADRD scientists, especially scientists with the unique training and skills necessary to design and perform clinical trials. This training is rarely provided through the traditional course of medical or biostatistical education. As a result, there is a dearth of well-trained ADRD clinical trialists. Moreover, there is very limited diversity among the current group of active ADRD trial investigators. To develop improved therapies for ADRD, multidisciplinary expertise in clinical trials will be necessary, including medical specialists but also expertise in biostatistics, trial design, biomarkers, ethics, and informatics. This proposal requests support to establish a first-of-its-kind training program in the essential elements of ADRD trials. The Institute on Methods and Protocols for the Advancement of Clinical Trials in ADRD (IMPACT-AD) Course will leverage the full infrastructure and expertise of the Alzheimer's Clinical Trials Consortium (ACTC) affiliated faculty. IMPACT-AD will be conducted annually to attract and train the next generation of ADRD clinical trialists, with a particular focus on improving the diversity of ADRD clinical investigators across race/ethnicity, gender, and scientific/professional backgrounds. IMPACT-AD seeks to provide a diverse range of clinicians, scientists and researchers with a modern and robust training in the design and conduct of ADRD clinical trials.