PDF(Pubmed)
Abstract：
BACKGROUND: The results and data availability of vaccine trials directly affect the decisions of healthcare providers, the public, and policymakers as to whether the vaccine should be applied. However, the reporting and data sharing level of COVID-19 vaccine studies are not clear.
METHODS: A cross-sectional study was conducted. A systematic search up to 9 May 2021 in 12 databases and an updated search to 6 July 2021 were conducted in the Cochrane Living Systematic Review and Network Meta-Analysis database to identify COVID-19 vaccine trials. The basic characteristics of included trials were summarized. The reporting level was assessed according to the CONSORT checklist. The data sharing level was assessed by open science practices. Types of incomplete reporting including protocol deviation, lack of primary outcomes clarity, and the omission of harms were analyzed.
RESULTS: Finally, thirty-six COVID-19 vaccine articles reporting on 40 randomized controlled trials were included in this analysis. Based on the CONSORT checklist, the mean reporting score was 29.7 [95% confidence interval 28.7, 30.7]. Thirty-one articles (31/36, 86.1%) had data sharing statements, twenty-five articles (25/36, 69.4%) provided access to the source data. Twenty-seven articles (27/36, 75.0%) had protocol deviation, lack of primary outcomes clarity, or the omission of harms.
CONCLUSIONS: The reporting and data sharing level of COVID-19 vaccine trials were not optimal. We hope that the reporting and data sharing of future trials will be improved. We recommend establishing a comprehensive, accurate data sharing system for future vaccine trials.
BACKGROUND: This work was supported by the National Key R&D Program of China (2019YFC1710400; 2019YFC1710403).
METHODS: A cross-sectional study was conducted. A systematic search up to 9 May 2021 in 12 databases and an updated search to 6 July 2021 were conducted in the Cochrane Living Systematic Review and Network Meta-Analysis database to identify COVID-19 vaccine trials. The basic characteristics of included trials were summarized. The reporting level was assessed according to the CONSORT checklist. The data sharing level was assessed by open science practices. Types of incomplete reporting including protocol deviation, lack of primary outcomes clarity, and the omission of harms were analyzed.
RESULTS: Finally, thirty-six COVID-19 vaccine articles reporting on 40 randomized controlled trials were included in this analysis. Based on the CONSORT checklist, the mean reporting score was 29.7 [95% confidence interval 28.7, 30.7]. Thirty-one articles (31/36, 86.1%) had data sharing statements, twenty-five articles (25/36, 69.4%) provided access to the source data. Twenty-seven articles (27/36, 75.0%) had protocol deviation, lack of primary outcomes clarity, or the omission of harms.
CONCLUSIONS: The reporting and data sharing level of COVID-19 vaccine trials were not optimal. We hope that the reporting and data sharing of future trials will be improved. We recommend establishing a comprehensive, accurate data sharing system for future vaccine trials.
BACKGROUND: This work was supported by the National Key R&D Program of China (2019YFC1710400; 2019YFC1710403).
摘要：
背景：疫苗试验的结果和数据可用性直接影响医疗保健提供者的决策，公众,以及政策制定者是否应该使用疫苗。然而,COVID-19疫苗研究的报告和数据共享水平尚不清楚。
方法：进行横断面研究。在2021年5月9日之前在12个数据库中进行了系统搜索，并在CochraneLiving系统评价和网络荟萃分析数据库中进行了到2021年7月6日的更新搜索，以确定COVID-19疫苗试验。总结纳入试验的基本特征。根据CONSORT检查表评估报告水平。数据共享水平通过开放科学实践进行评估。不完整报告的类型，包括方案偏差，缺乏主要结果的清晰度，并对遗漏的危害进行了分析。
结果：最后，本分析纳入了36篇报告40项随机对照试验的COVID-19疫苗文章。根据CONSORT清单，平均报告评分为29.7分[95%置信区间28.7,30.7].31篇文章(31/36，86.1%)有数据共享声明，25篇文章(25/36，69.4%)提供了对源数据的访问。27篇(27/36，75.0%)有协议偏差，缺乏主要结果的清晰度，或者遗漏危害。
结论：COVID-19疫苗试验的报告和数据共享水平并不理想。我们希望未来审判的报告和数据共享将得到改进。我们建议建立一个全面的，未来疫苗试验的准确数据共享系统。
背景：这项工作得到了中国国家重点研发计划（2019YFC1710400；2019YFC1710403）的支持。
方法：进行横断面研究。在2021年5月9日之前在12个数据库中进行了系统搜索，并在CochraneLiving系统评价和网络荟萃分析数据库中进行了到2021年7月6日的更新搜索，以确定COVID-19疫苗试验。总结纳入试验的基本特征。根据CONSORT检查表评估报告水平。数据共享水平通过开放科学实践进行评估。不完整报告的类型，包括方案偏差，缺乏主要结果的清晰度，并对遗漏的危害进行了分析。
结果：最后，本分析纳入了36篇报告40项随机对照试验的COVID-19疫苗文章。根据CONSORT清单，平均报告评分为29.7分[95%置信区间28.7,30.7].31篇文章(31/36，86.1%)有数据共享声明，25篇文章(25/36，69.4%)提供了对源数据的访问。27篇(27/36，75.0%)有协议偏差，缺乏主要结果的清晰度，或者遗漏危害。
结论：COVID-19疫苗试验的报告和数据共享水平并不理想。我们希望未来审判的报告和数据共享将得到改进。我们建议建立一个全面的，未来疫苗试验的准确数据共享系统。
背景：这项工作得到了中国国家重点研发计划（2019YFC1710400；2019YFC1710403）的支持。
