Madi Karima, Flumian Clara, Olivier Pascale, Sommet Agnès, Montastruc François
CIC 1436, Team PEPSS (Pharmacologie En Population cohorteS et biobanqueS), Toulouse University Hospital, Toulouse, France.
Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
BMJ Med. 2023 Sep 21;2(1):e000352. doi: 10.1136/bmjmed-2022-000352. eCollection 2023.
To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on ClinicalTrials.gov.
Systematic review.
PubMed and ClinicalTrials.gov registries were searched from 1 December 2019 to 17 February 2022.
Randomised clinical trials evaluating the efficacy and safety of drugs used to treat covid-19 disease in participants of all ages with suspected, probable, or confirmed SARS-CoV-2 infection were included. Clinical trials were screened on title, abstract, and text by two authors independently. Only articles published in French and English were selected. The Cochrane risk of bias tool for randomised trials (RoB 2) was used to assess risk of bias.
The search strategy identified 1962 randomised clinical trials assessing the efficacy and safety of drugs used to treat covid-19, published in the PubMed database; 1906 articles were excluded after screening and 56 clinical trials were included in the review. Among the 56 clinical trials, no study had a high score for quality of reporting of adverse events, 60.7% had a moderate score, 33.9% had a low score, and 5.4% had a very low score. All clinical trials with a very low score for quality of reporting of adverse events were randomised open label trials. For reporting of serious adverse events, journal articles published on PubMed under-reported 51% of serious adverse events compared with clinical trial summaries published on ClinicalTrials.gov.
In one in three published clinical trials on covid-19 drugs, the quality of reporting of adverse events was low or very low. Differences were found in the number of serious adverse events reported in journal articles versus clinical trial summaries. During the covid-19 pandemic, risk assessment of drugs in clinical trials of covid-19 drugs did not comply with good practice recommendations for publication of results.
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) EUPAS45959.
基于CONSORT（临床试验报告统一标准）危害扩展版并根据临床试验设计，评估新冠药物临床试验中不良事件的报告质量，并比较在PubMed上发表的药物试验与ClinicalTrials.gov上的临床试验总结中严重不良事件的报告情况。
系统评价。
检索2019年12月1日至2022年2月17日期间的PubMed和ClinicalTrials.gov注册库。
纳入评估用于治疗疑似、可能或确诊的SARS-CoV-2感染的各年龄段参与者的新冠疾病治疗药物疗效和安全性的随机临床试验。由两位作者独立根据标题、摘要和正文对临床试验进行筛选。仅选择以法语和英语发表的文章。使用Cochrane随机试验偏倚风险工具（RoB 2）评估偏倚风险。
检索策略在PubMed数据库中识别出1962项评估新冠治疗药物疗效和安全性的随机临床试验；筛选后排除1906篇文章，56项临床试验纳入综述。在这56项临床试验中，没有研究在不良事件报告质量方面获得高分，60.7%为中等分数，33.9%为低分，5.4%为极低分。所有不良事件报告质量极低分的临床试验均为随机开放标签试验。对于严重不良事件的报告，与ClinicalTrials.gov上发表的临床试验总结相比，PubMed上发表的期刊文章少报告了51%的严重不良事件。
在三分之一已发表的新冠药物临床试验中，不良事件的报告质量较低或非常低。在期刊文章与临床试验总结中报告的严重不良事件数量方面存在差异。在新冠疫情期间，新冠药物临床试验中的药物风险评估未遵循结果发表的良好实践建议。
欧洲药物流行病学和药物警戒中心网络（ENCePP）EUPAS45959。
