Aisen P, Touchon J, Andrieu S, Boada M, Doody R, Nosheny R L, Langbaum J B, Schneider L, Hendrix S, Wilcock G, Molinuevo J L, Ritchie C, Ousset P-J, Cummings J, Sperling R, DeKosky S T, Lovestone S, Hampel H, Petersen R, Legrand V, Egan M, Randolph C, Salloway S, Weiner M, Vellas B
Paul Aisen, Alzheimer's Therapeutic Research Institute (ATRI), Keck School of Medicine, University of Southern California, San Diego, CA, USA.
J Prev Alzheimers Dis. 2016;3(2):68-74. doi: 10.14283/jpad.2016.97.
The EU/US/CTAD Task Force, an international collaboration of AD investigators from industry and academia, met in Barcelona, Spain, on November 4th, 2015, to explore existing and planned patient registries and other clinical trial infrastructure meant to expedite recruitment of large numbers of participants into clinical trials and improve their productivity. The Task Force identified a number of approaches currently being tested around the world, including the use of predictive algorithms to identify individuals likely to have prodromal or preclinical AD, the establishment of clinical trial networks to streamline trials, and reforming the informed consent process to make it less burdensome to both investigators and trial participants. Multi-national systems such as the European Prevention of Alzheimer's Dementia (EPAD) and the Global Alzheimer's Platform (GAP) offer value for sponsors, trial sites, and patients by optimizing efforts to find effective disease-modifying and symptomatic treatments.
欧盟/美国/CTAD特别工作组由来自行业和学术界的阿尔茨海默病研究人员组成,是一个国际合作组织。该组织于2015年11月4日在西班牙巴塞罗那召开会议,探讨现有的和计划中的患者登记系统以及其他临床试验基础设施,旨在加快大量参与者进入临床试验的招募速度并提高其效率。特别工作组确定了目前在全球范围内正在测试的一些方法,包括使用预测算法来识别可能患有前驱期或临床前阿尔茨海默病的个体、建立临床试验网络以简化试验,以及改革知情同意程序,使其对研究人员和试验参与者的负担都更小。像欧洲预防阿尔茨海默病痴呆症(EPAD)和全球阿尔茨海默病平台(GAP)这样的跨国系统,通过优化寻找有效的疾病修饰和对症治疗的努力,为申办者、试验地点和患者提供了价值。