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. 2020 Jul 7;95(1):29-36.
doi: 10.1212/WNL.0000000000009698. Epub 2020 May 1.

The CREST-2 experience with the evolving challenges of COVID-19: A clinical trial in a pandemic

James F Meschia  1 , Kevin M Barrett  2 , Robert D Brown Jr  2 , Tanya N Turan  2 , Virginia J Howard  2 , Jenifer H Voeks  2 , Brajesh K Lal  2 , George Howard  2 , Thomas G Brott  2
Affiliations

The CREST-2 experience with the evolving challenges of COVID-19: A clinical trial in a pandemic

James F Meschia et al. Neurology. .

Abstract

The coronavirus disease 2019 pandemic has disrupted the lives of whole communities and nations. The multinational multicenter National Institute of Neurological Disorders and Stroke Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial stroke prevention trial rapidly experienced the effects of the pandemic and had to temporarily suspend new enrollments and shift patient follow-up activities from in-person clinic visits to telephone contacts. There is an ethical obligation to the patients to protect their health while taking every feasible step to ensure that the goals of the trial are successfully met. Here, we describe the effects of the pandemic on the trial and steps that are being taken to mitigate the effects of the pandemic so that trial objectives can be met.

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References

    1. Zhou P, Yang XL, Wang XG, et al. . A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature 2020;579:270–273. - PMC - PubMed
    1. Holshue ML, DeBolt C, Lindquist S, et al. . First case of 2019 novel coronavirus in the United States. N Engl J Med 2020;382:929–936. - PMC - PubMed
    1. Murray CJL. Forecasting COVID-19 impact on hospital bed-days, ICU-days, ventilator days and deaths by US state in the next 4 months. IMHE web page. Avaiable at: healthdata.org/research-article/forecasting-covid-19-impact-hospital-bed.... Accessed April 2, 2020.
    1. Trachtman H, Caplan A. Data monitoring committees and stopping trials—giving participants a voice. Contemp Clin Trials 2018;68:146. - PubMed
    1. Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA 1982;248:968–970. - PubMed

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