Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review

Objective To assess the quality of reporting adverse events in clinical trials covid-19 drugs based on CONSORT (Consolidated Standards Reporting Trials) harms extension and according to trial design, examine serious drug published PubMed versus summaries ClinicalTrials.gov. Design Systematic review. Data sources ClinicalTrials.gov registries were searched from 1 December 2019 17 February 2022. Eligibility criteria for selecting studies Randomised evaluating efficacy safety used treat disease participants all ages with suspected, probable, or confirmed SARS-CoV-2 infection included. Clinical screened title, abstract, text by two authors independently. Only articles French English selected. The Cochrane risk bias tool randomised (RoB 2) was bias. Results search strategy identified 1962 assessing covid-19, database; 1906 excluded after screening 56 included Among trials, no study had a high score events, 60.7% moderate score, 33.9% low 5.4% very score. All open label trials. For journal under-reported 51% compared Conclusions In one three drugs, low. Differences found number reported summaries. During pandemic, assessment did not comply good practice recommendations publication results. review registration European Network Centres Pharmacoepidemiology Pharmacovigilance (ENCePP) EUPAS45959.