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Core Concept: In the wake of COVID-19, decentralized clinical trials move to center stage
Thursday, 2021/11/25 | 07:30:24

Marcus A. Banks

PNAS November 23, 2021 118 (47) e2119097118

 

Figure: Smartwatches are among the technologies that can facilitate large, decentralized trials. Patients monitor aspects of their health as they go about their daily lives. Image credit: Shutterstock/Andrey_Popov.

 

In January 2021, New York’s Northwell Health hospital system launched a clinical trial to learn whether the over-the-counter drug famotidine (also known as Pepcid) reduces the severity of COVID-19 in symptomatic patients who do not require hospitalization. The randomized trial began in response to anecdotal reports along with clinical studies showing that Pepcid benefited COVID-19 patients (1). But the trial had a twist: It was completely virtual; no visits to a research site required (2). In fact, it was the first fully virtual clinical trial for the health system. Northwell leaders say it won’t be the last.

 

“COVID has sped up this process, and for the better,” says Christina Brennan, VP for clinical research at Northwell’s Feinstein Institutes for Medical Research. Brennan says that the initial design for the trial called for on-site visits, and that trial leaders pivoted upon realizing that prospective participants preferred to recuperate at home. The virtual model has enabled Northwell to recruit a more diverse set of participants than in its other trials, Brennan says, perhaps because on-site visits were not a barrier. Drugs (either Pepcid or placebo) were mailed to participants, and all laboratory draws were done at their home. The trial, which Northwell conducted in partnership with the Cold Spring Harbor Laboratory, NY, has concluded enrollment as of September 2021. Data analysis is ongoing.

 

See more: https://www.pnas.org/content/118/47/e2119097118

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