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Randomized clinical trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier lives. As of March 2020, ClinicalTrials.gov listed 262 366 ongoing randomized clinical trials, including 146 420 trials studying drug or biologic interventions, 85 045 trials of behavioral interventions, and 61 351 trials of surgical or device interventions.1 Suddenly, and quite dramatically, the coronavirus pandemic threatens the integrity of these clinical trials. The National Institutes of Health has advised investigators to consult with their institutional review boards and institutions about potential measures to protect participants and research staff. Responses from academic medical center and other research groups have varied from mandatory suspension of research involving human participants (except when this increases risk to participants) to relying on principal investigator discretion.
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Corresponding Author: Mary M. McDermott, MD, Department of Medicine, Feinberg School of Medicine, Northwestern University, 750 N Lake Shore Dr, 10th Floor, Chicago, IL 60611 (firstname.lastname@example.org).
Published Online: March 25, 2020. doi:10.1001/jama.2020.4689
Conflict of Interest Disclosures: Dr McDermott reported receiving grants from the National Heart, Lung, and Blood Institute, National Institute on Aging, American Heart Association, and Regeneron; financial support for intervention for clinical trials from Helixmith, Hershey, Chromadex, ArtAssist, and ReserveAge; and nonfinancial support from Mars Inc. Dr Newman reported no disclosures.
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