Quality of adverse event reporting in clinical trials of remdesivir in patients with COVID-19
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LETTER TO THE EDITOR
Quality of adverse event reporting in clinical trials of remdesivir in patients with COVID-19 Chia Siang Kow 1
&
Mamoon Aldeyab 2 & Syed Shahzad Hasan 2,3
Received: 12 August 2020 / Accepted: 23 September 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Remdesivir appears to be promising in the treatment of novel coronavirus disease 2019 (COVID-19). However, the evaluation of the effectiveness of remdesivir should be done in parallel with the analysis of its adverse events since only little is known about its safety. In fact, the reporting of a case of symmetrical drug–related intertriginous and flexural exanthema related to the administration of remdesivir in a patient with COVID-19 by Heck et al. [1] indicates a risk signal on the use of this newly approved agent. The medical community is heavily relying on the clinical trials to inform the possible harms of remdesivir. We undertake the evaluation of the quality of adverse event (AE) reporting in clinical trials [2–5] of remdesivir in patients with COVID-19 based on adherence to the recommendations from the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for better reporting of harms [6]. However, there are multiple items of interest within a single CONSORT harms recommendation, and thus scoring the multiple items within a single recommendation would be difficult and misleading. Therefore, we employed the validated methods by Hadi et al. [7] to split each single CONSORT harms recommendation into two or three items resulting in a 19-item checklist. Each item of the 19-item checklist was scored individually and weighted with equal importance in line with CONSORT recommendations. Each item carries a score of ‘1’ if it was adequately reported or ‘0’ if it was not adequately reported or not reported at all. The total harm reporting score was calculated by summing up all the
* Chia Siang Kow [email protected] 1
School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia
2
School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom
3
School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, Australia
individual scores, where the total harm reporting score could range from 0 (worst possible score) to 19 (best possible score). Based on the total harm reporting score, we classified the quality of reporting of the adverse event into ‘high’ (score of 15-19), moderate (score of 10-14), low (score of 5-9), and very low (score 0-4). The adequacy of the three clinical trials of remdesivir in COVID-19 fulfilling each of the CONSORT harms recommendations is presented in Table 1. The trial by Wang et al. [2] had a total harm reporting score of 10. Both the trials by Beigel et al. [3] and Goldman et al. [4] had a total harm reporting score of 9. Whereas the trial by Spinner et al. [5] had a total harm reporting score of 8. None of the clinical trials provided information on AEs in the introduction section (CONSORT recommen
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