2020
DOI: 10.1038/s41390-020-01260-1
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Bringing research directly to families in the era of COVID-19

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Cited by 7 publications
(3 citation statements)
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References 12 publications
(15 reference statements)
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“…We encountered several legal challenges related to conducting in-home clinical trial activities on a national scale. 30 First, we clearly delineated that we were conducting teleresearch, not telemedicine. Although we were studying a device-based intervention, and not a prescribed study drug, participants may nevertheless perceive in-home assessments as diagnosis and treatment.…”
Section: Trial Design and Implementation Considerationsmentioning
confidence: 99%
“…We encountered several legal challenges related to conducting in-home clinical trial activities on a national scale. 30 First, we clearly delineated that we were conducting teleresearch, not telemedicine. Although we were studying a device-based intervention, and not a prescribed study drug, participants may nevertheless perceive in-home assessments as diagnosis and treatment.…”
Section: Trial Design and Implementation Considerationsmentioning
confidence: 99%
“…However, the fundamental premise in clinical research of testing the safety and efficacy of therapeutics under controlled conditions has been significantly impacted by the pandemic’s health concerns about congregate settings and ongoing social distancing requirements. In the spring of 2020, public health measures all over the globe (including mandatory lockdowns, institutional guidelines and individual behavior patterns) combined to bring clinical trials virtually to a halt [ 1–5 ]. As of January 2021 there were more than 2000 clinical trials that had been stopped explicitly due to COVID-19 restrictions [ 6 ].…”
Section: Clinical Trial Disruption and Opportunitymentioning
confidence: 99%
“…However, as some parents cited a desire to discuss participation with the other parent prior to consenting, this may suggest that the policy is responsible in some way for the decrease in recruitment. Newer methods for research studies including direct-to-family study design, in which recruitment, intervention, and data collection all occur remotely (e.g., in participants’ homes), 12 require additional technology.…”
Section: Children and Familiesmentioning
confidence: 99%