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Clinical Trials and Tribulations in the COVID-19 Era.
The American Journal of Geriatric Psychiatry ( IF 7.2 ) Pub Date : 2020-05-19 , DOI: 10.1016/j.jagp.2020.05.016
Marc Scott Weinberg 1 , Regan E Patrick 2 , Nadine A Schwab 3 , Praise Owoyemi 4 , Rose May 4 , Alison J McManus 5 , Jessica Gerber 5 , David G Harper 6 , Steven E Arnold 5 , Brent Forester 6
Affiliation  

Advances in treating and preventing Alzheimer disease and other neurocognitive disorders of aging arise from rigorous preclinical and clinical research, with randomized controlled treatment trials as the last and definitive test. The COVID-19 pandemic has greatly disrupted ongoing interventional studies and researchers are scrambling to find ways to safely continue this critical work amidst rapidly shifting guidelines from sponsors, institutions, and state and federal guidelines. Here the authors describe novel approaches and work-flow adaptations to study visits, drug delivery and interim and endpoint safety and outcomes assessments to avoid sacrificing years of preparation and substantial financial investments, to work in the best interest of participants and their caregivers, and to continue on the path toward discovering disease-modifying treatments for the millions of individuals impacted by major neurocognitive disorders.



中文翻译:

COVID-19 时代的临床试验和磨难。

治疗和预防阿尔茨海默病和其他衰老神经认知障碍的进展源于严格的临床前和临床研究,随机对照治疗试验是最后的决定性测试。COVID-19 大流行极大地扰乱了正在进行的介入研究,研究人员正在努力寻找方法,在赞助商、机构以及州和联邦指导方针迅速变化的情况下安全地继续这项关键工作。在这里,作者描述了研究访问、药物输送以及中期和终点安全性和结果评估的新方法和工作流程调整,以避免牺牲多年的准备和大量的财务投资,以参与者及其护理人员的最大利益为出发点,并继续为数百万受主要神经认知障碍影响的人寻找缓解疾病的治疗方法。

更新日期:2020-05-19
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