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Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
Thorlund et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339 (Review)
Thorlund et al., Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial, The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339 (Review)
Mar 2022   Source   PDF  
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Discussion of concerns with the MOVe-OUT trial, including the reversal of the treatment effect post-interim analysis.
Thorlund et al., 11 Mar 2022, peer-reviewed, 5 authors.
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Abstract: In order to provide our readers with timely access to new content, papers accepted by the American Journal of Tropical Medicine and Hygiene are posted online ahead of print publication. Papers that have been accepted for publication are peer-reviewed and copy edited but do not incorporate all corrections or constitute the final versions that will appear in the Journal. Final, corrected papers will be published online concurrent with the release of the print issue. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Am. J. Trop. Med. Hyg., 00(00), 2022, pp. 1–4 doi:10.4269/ajtmh.21-1339 Copyright © 2022 by The American Society of Tropical Medicine and Hygiene Perspective Piece Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial Kristian Thorlund,1* Kyle Sheldrick,2 Gideon Meyerowitz-Katz,3 Sonal Singh,4 and Andrew Hill5 1 Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada; 2University of New South Wales, Kensington, Australia; 3School of Health and Society, University of Wollongong, New South Wales, Australia; 4Department of Family Medicine and Community Health, UMass Chan Medical School, Worcester, Massachusetts; 5Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, United Kingdom Abstract. Oral therapies for the early treatment of COVID-19 may prevent disease progression and health system overcrowding. A new oral therapeutic named molnupiravir has been promoted as providing an approximately 50% reduction in death or the need for hospitalization. The clinical trial evaluating this drug was stopped early at the recommendation of the Data Safety and Monitoring Board after approximately 50% of the sample had been recruited. At the point of discontinuing the trial, approximately 90% of the planned sample had been recruited and had available follow-up data accessible. We discuss issues about the study conduct, analysis, and interpretation, including 1) the authors and sponsors presented the interim analysis as the primary analysis; 2) communication between sponsors and the Data Safety and Monitoring Board was insufficient; 3) the treatment effects reverse when examining only the post-interim analysis population, and are substantially attenuated when examining the full data; 4) the choice of primary analysis is incorrect; 5) analysis of lost-to-follow-up patients favors the study drug; and 6) other known molnupiravir trials were not presented in the primary study findings. As a result of methodological and statistical concerns, it seems that external trials, separate from those supported by the sponsoring company, are required to determine the utility of this drug. Since the COVID-19 pandemic began, there has been a need for effective vaccines and treatments. The early vaccine trials allowed rapid development and deployment of highly effective vaccines, but treatments for COVID-19 have been slow to develop. The greatest successes among treatments have been those conducted in patients with advanced disease in hospitals.1 Much more elusive have been interventions for early treatment of COVID-19, when patients are not yet hospitalized.1 Clinical trials in this population are challenging because most patients will never be hospitalized regardless of interventions so..
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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