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COVID-19

Session: Poster Session A

(136) Quality of Adverse Events Reporting in Clinical Trials of COVID-19 Drugs: a systematic review

Friday, August 25, 2023
8:00 AM – 6:00 PM ADT
Location: Convention Hall
Publication Number: 472

    Presenting Author(s)

  • Francois Montastruc, MD, PHD

    MD, PhD
    Department of Medical and Clinical Pharmacology, Centre of Pharmaco Vigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, 37 Allées Jules Guesde, Toulouse, 31000, France.
    Toulouse, France

Background: While a preliminary review of clinical trials evaluating remdesivir for COVID-19 highlighted a poor accuracy adverse event reporting, no large evaluation is available to other drugs used for COVID-19 treatment.

Objectives: This systematic review aims to assess the quality of adverse events (AEs) reporting in clinical trials of COVID-19 drugs, including antibodies, antivirals and immunomodulators.

Methods: Using Medline and ClinicalTrial.gov registries, two authors independently selected clinical trials published between December 2019 to February 2022 of COVID-19 drugs. This study used The PRISMA guidelines for the study design, search protocol, screening, and reporting. To assess the quality of AEs reporting, we used the Consolidated Standards of Reporting Trials (CONSORT) for Harms statement. Our systematic review protocol was registered with the international Encepp on March 21, 2022 (Registration number: EUPAS45959).

Results: Among the 56 clinical trials included in the study, we showed that no study has a high quality of AEs reporting, 60.7% had moderate quality score while 33.9% had low and 5.4% had very low quality score. All clinical trials with very low quality of AEs reporting are randomized open-label trials. In the comparison of SAEs reporting in journal articles published on PubMed and clinical trial summaries published in ClinicalTrial.gov, we reported that journal articles under-report 49% of SAEs than clinical trial summaries.

Conclusions: In one in three published clinical trials on COVID-19 drugs, quality of AE reporting was low or very low. Wide discrepancies were found on number of SAEs reported between journal articles and clinical summaries. During the COVID-19 pandemic, drug risk assessment in clinical trials of COVID-19 drugs did not comply with good practice recommendations for publication of results. Due to the poor accuracy of harm data, an assessment of the benefits/risks balance of COVID-19 drugs based on the results reported in trial publications is biased.