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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
Mar 2022  
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Discussion of concerns with the MOVe-OUT trial, including the reversal of the treatment effect post-interim analysis.
Reviews covering molnupiravir for COVID-19 include Anonymous, Bacigalupo, Goldstein, Hadj Hassine, Kosakovsky Pond, Malone, Swanstrom, Waters.
Thorlund et al., 11 Mar 2022, peer-reviewed, 5 authors.
This PaperMolnupiravirAll
Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
Kristian Thorlund, Kyle Sheldrick, Gideon Meyerowitz-Katz, Sonal Singh, Andrew Hill
The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339
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.
References
Arribas, on behalf of the MOVe-IN study group, 2022. Randomized trial of molnupiravir or placebo in patients hospitalized with COVID-19, NEJM Evid
Balakrishnan, Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir Conducted in India
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Kumarasamy, Saha, Jindal, Singh, Rodduturi et al., Phase III trial of molnupiravir in adults with mild SARS-COV2 infection in India (Abstract #101
Lakens, P-hacking and Optional Stopping Have Been Judged Violations of Scientific Integrity
Merck, Merck Statement on Clinical Data for Molnupiravir Generated by Hetero in India
News, Merck and Ridgeback's Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study
Park, Decloedt, Rayner, Cotton, Mills, Clinical trials of disease stages in COVID 19: complicated and often misinterpreted, Lancet Glob Health
Perappadan, Molnupiravir Kept Out of Revised Clinical Guidelines for Management of Adult COVID-19 Patients
Siemieniuk, Drug treatments for COVID-19: living systematic review and network meta-analysis, BMJ
Singh, Mitra, Arora, Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
Spencer, Parodi, France Cancels Order for Merck's COVID-19 Antiviral Drug
Tandon, Molnupiravir Harms Far Outweigh Claimed Benefits: ICMR's Second Warning in a Week
The, Group, Patient-Reported Outcomes: 17b: Binary Outcomes
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