Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13,694 patients
Jack Lawrence, Manya Mirchandani, Andrew Hill
doi:10.21203/rs.3.rs-1913200/v1
During the COVID-19 pandemic, Merck Sharp and Dohme (MSD) acquired the global licensing rights for molnupiravir. MSD allowed Indian manufacturers to produce the drug under voluntary license. Indian companies conducted local clinical trials to evaluate the e cacy and safety of molnupiravir.
Methods Searches of the Clinical Trials Registry-India (CTRI) were conducted to nd registered trials of molnupiravir in India. Subsequent investigations were performed to assess which clinical trials had been presented or published.
Results According to the CTRI, 12 randomised trials of molnupiravir were conducted in India, in 13,694 patients, starting in late May 2021. By July 2022, none of the 12 trials has been published, one was presented at a medical conference, and two were announced in press releases suggesting failure of treatment. Results from three trials were shared with the World Health Organisation. One of these three trials had many unexplained results, with effects of treatment signi cantly different from the MSD MOVE-OUT trial in a similar population.
Discussion The lack of results runs counter to established practices and leaves a situation where approximately 90% of the global data on molnupiravir has not been published in any form. Access to patient-level databases is required to investigate risks of bias or medical fraud.
is approaching 12 months since most of the 12 Indian trials concluded. While it is concerning that data from so many patients is missing, the circumstances are worsened because there is currently nothing to prevent the same situation from reoccurring with another drug.
Declarations The authors declare no con icts of interest. This research was funded by the International Treatment Preparedness Coalition / Make Medicines Affordable Campaign.
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