The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD): A Novel Clinical Trials Training Program.
The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD): A Novel Clinical Trials Training Program.
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DOI：
10.14283/jpad.2021.12
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发表时间：
2021
影响因子：
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通讯作者：
Grill JD
中科院分区：
文献类型：
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作者：
Berkness T;Carrillo MC;Sperling R;Petersen R;Aisen P;Flournoy C;Snyder H;Raman R;Grill JD
阿尔茨海默病和相关痴呆（ADRD）临床试验需要医学、生物统计学、试验设计、生物标志物、伦理学和信息学等多学科专业知识。为不同的研究人员提供ADRD临床试验的重点互动培训。ADRD临床试验方法与方案研究所（IMPACT-AD）是由美国国家衰老研究所和阿尔茨海默病协会资助的一个新的多学科临床试验培训项目，有两个教育轨道。专业人员跟踪包括填补各种角色的个人，包括临床医生，研究协调员，心理测量学家和其他希望在ADRD试验中进一步了解和推进其职业生涯的研究专业人员。研究人员包括当前和未来的主要研究人员，并专注于ADRD临床试验的设计、实施和分析。2020年IMPACT-AD的首次迭代是通过Zoom举行的。从104份申请（录取率34%）中选出35名学员（研究员15名，专业人员20名）。大多数（n=25, 71%）被确定为女性。其中15人（43%）是非白人；6人（18%）为西班牙裔；8人（23%）表示他们是家里第一个上大学的人。参与者完成了日常评估以及课程前和课程后的学习评估。在各个主题领域，大约90%的学员认为他们在讲座中获得的知识变化“非常多”或“有所增加”。专业培训课程的课程前和课程后评估的平均正确率从55%提高到75%，研究人员培训课程的平均正确率从54%提高到78%。在全球大流行病背景下，IMPACT-AD成功启动了一个新的培训机会，初步实现了吸引多样化学员和提供有意义培训的目标。该课程的资助将持续到2025年。
Alzheimer’s Disease and Related Dementias (ADRD) clinical trials require multidisciplinary expertise in medicine, biostatistics, trial design, biomarkers, ethics, and informatics. To provide focused interactive training in ADRD clinical trials to a diverse cadre of investigators. The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD) is a novel multidisciplinary clinical trial training program funded by the National Institute on Aging and the Alzheimer’s Association with two educational tracks. The Professionals track includes individuals who fill a broad variety of roles including clinicians, study coordinators, psychometricians, and other study professionals who wish to further their knowledge and advance their careers in ADRD trials. The Fellowship track includes current and future principal investigators and focuses on the design, conduct and analysis of ADRD clinical trials. The 2020 inaugural iteration of IMPACT-AD was held via Zoom. Thirty-five trainees (15 Fellowship track; 20 Professionals track) were selected from 104 applications (34% acceptance rate). Most (n=25, 71%) identified as female. Fifteen (43%) were of a non-white race; six (18%) were of Hispanic ethnicity; eight (23%) indicated they were the first person in their family to attend college. Participants completed daily evaluations as well as pre- and post-course assessments of learning. Across topic areas, >90% of trainees evaluated their change in knowledge based on the lectures as “very much” or “somewhat increased.” The mean proportion correct responses in pre- and post-course assessments increased from 55% to 75% for the Professionals track and from 54% to 78% for the Fellowship track. IMPACT-AD successfully launched a new training opportunity amid a global pandemic that preliminarily achieved the goals of attracting a diverse cohort and providing meaningful training. The course is funded through 2025.