1. Optimizing telemedicine to facilitate amyotrophic lateral sclerosis clinical trials.
- Author
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Govindarajan R, Berry JD, Paganoni S, Pulley MT, and Simmons Z
- Subjects
- Amyotrophic Lateral Sclerosis complications, COVID-19, Clinical Trials as Topic, Coronavirus Infections epidemiology, Humans, Pneumonia, Viral epidemiology, SARS-CoV-2, Amyotrophic Lateral Sclerosis diagnosis, Betacoronavirus, Coronavirus Infections complications, Pandemics, Pneumonia, Viral complications, Quality of Life, Telemedicine methods
- Abstract
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., (© 2020 Wiley Periodicals, Inc.)
- Published
- 2020
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