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Remote Research and Clinical Trial Integrity During and After the Coronavirus Pandemic

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

Approximately 1 year ago, in March 2020, clinical trials were suddenly and severely disrupted by the COVID-19 pandemic. Pandemic-related restrictions that limited or prevented in-person visits resulted in unprecedented obstacles to clinical trial enrollment, data collection, and intervention delivery for many clinical trials.1 As of April 21, 2021, ClinicalTrials.gov listed 1773 suspended clinical trials, with many trials identifying the COVID-19 pandemic as the primary reason for suspension. Ongoing trials that were not suspended are likely to be experiencing challenges with enrollment and fidelity to aspects of study protocols that require in-person contact, including interventions and outcome assessment.

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Article Information

Corresponding Author: Mary McGrae McDermott, MD, 750 N Lake Shore Dr, 10th Floor, Chicago, IL 60611 (mdm608@northwestern.edu).

Published Online: April 22, 2021. doi:10.1001/jama.2021.4609

Conflict of Interest Disclosures: Dr McDermott reported receiving grants from the National Heart, Lung, and Blood Institute, National Institute on Aging (NIA), American Heart Association, and Regeneron, other support from Helixmith, and research support from Mars Inc, Hershey, Art Assist, Chromadex, and ReserveAge. Dr Newman reported receiving grants from the National Institutes of Health.

Funding/Support: Supported, in part, by grants P30AG059988 and P30AG024827 from the NIA.

Role of the Funder/Sponsor: The NIA had no role in the preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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