Welsh-Bohmer Kathleen A, Kerchner Geoffrey A, Dhadda Shobha, Garcia Miguel, Miller David S, Natanegara Fanni, Raket Lars Lau, Robieson Weining, Siemers Eric R, Carrillo Maria C, Weber Christopher J
Department of Psychiatry & Neurology Duke University Durham North Carolina USA.
Pharma Research and Early Development F. Hoffmann-La Roche, Ltd Basel Switzerland.
Alzheimers Dement (N Y). 2023 Oct 18;9(4):e12421. doi: 10.1002/trc2.12421. eCollection 2023 Oct-Dec.
The efficient and accurate execution of clinical trials testing novel treatments for Alzheimer's disease (AD) is a critical component of the field's collective efforts to develop effective disease-modifying treatments for AD. The lengthy and heterogeneous nature of clinical progression in AD contributes to the challenges inherent in demonstrating a clinically meaningful benefit of any potential new AD therapy. The failure of many large and expensive clinical trials to date has prompted a focus on optimizing all aspects of decision making, to not only expedite the development of new treatments, but also maximize the value of the information that each clinical trial yields, so that all future clinical trials (including those that are negative) will contribute toward advancing the field. To address this important topic the Alzheimer's Association Research Roundtable convened December 1-2, 2020. The goals focused around identifying new directions and actionable steps to enhance clinical trial decision making in planned future studies.
对阿尔茨海默病（AD）新型治疗方法进行高效且准确的临床试验，是该领域为开发有效的疾病修饰治疗方法而共同努力的关键组成部分。AD临床进展的漫长且异质性特点，给证明任何潜在新AD疗法具有临床意义的益处带来了固有挑战。迄今为止，许多大型且昂贵的临床试验均告失败，这促使人们专注于优化决策的各个方面，不仅要加快新疗法的研发，还要使每项临床试验所产生信息的价值最大化，以便所有未来的临床试验（包括那些结果为阴性的试验）都能推动该领域的发展。为探讨这一重要话题，阿尔茨海默病协会研究圆桌会议于2020年12月1日至2日召开。会议目标聚焦于确定新方向和可采取的行动步骤，以加强未来计划研究中的临床试验决策。
