Optimizing telemedicine to facilitate amyotrophic lateral sclerosis clinical trials
Optimizing telemedicine to facilitate amyotrophic lateral sclerosis clinical trials
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DOI：
10.1002/mus.26921
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发表时间：
2020-06-08
期刊：
影响因子：
3.4
通讯作者：
Simmons, Zachary
中科院分区：
文献类型：
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作者：
Govindarajan, Raghav;Berry, James D.;Simmons, Zachary
肌萎缩侧索硬化症（ALS）是神经肌肉疾病中最大的药物管道，有160多家公司积极参与ALS研究。招募试验参与者的需求越来越大，但ALS患者的活动能力往往有限，大多数ALS试验都是在少数主要中心进行的。这些因素实际上限制了患者的参与，特别是农村地区的患者。当前的2019冠状病毒病（COVID-19）大流行需要更广泛地使用远程医疗技术进行临床护理，并促使人们考虑增加其在临床试验中的使用。在这篇评论文章中，我们描述了远程医疗在招募、同意和筛选临床试验参与者方面的现状。我们还总结了远程管理的结果措施的可用数据。目前的挑战包括验证远程评估的结果措施，以及技术，监管和许可证障碍。
Amyotrophic lateral sclerosis (ALS) has the largest drug pipeline among neuromuscular diseases, with over 160 companies actively involved in ALS research. There is a growing need to recruit trial participants, but ALS patients often have limited mobility and most ALS trials are conducted in a small number of major centers. These factors effectively limit patient participation, particularly for those in rural areas. The current coronavirus disease 2019 (COVID-19) pandemic has necessitated the more widespread use of telemedicine technology for clinical care, and has prompted consideration of its increased use for clinical trials. In this opinion piece, we describe the current state of telemedicine for recruitment, consenting, and screening of participants for clinical trials. We also summarize the available data on remote administration of outcome measures. Current challenges include validation of outcome measures for remote assessment, as well as technological, regulatory, and licensure barriers.