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- Researchers from the Chinese and Canadian EQUATOR centres found insufficient reporting and data sharing from COVID-19 vaccine trials.<\/li>\n
- The researchers recommended real-time data sharing, and reporting guidelines for vaccine trials are due to be published later this year.<\/li>\n<\/ul>\n
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<\/p>\nOpen science continues to pick up steam, with transparency and data availability becoming a priority for both scientists and publishers. As we recently reported, World Health Organization (WHO<\/a>), the National Institutes of Health (NIH<\/a>), and Public Library of Science (PLOS<\/a>) all now require data sharing. The EQUATOR network is also now looking at how to improve both reporting and data sharing for vaccine trials.<\/p>\n
In a recent study, researchers from the Chinese <\/a>and Canadian<\/a> EQUATOR Centres evaluated<\/a> levels of reporting and data sharing in 36 articles on randomised controlled COVID-19 vaccine trials. In each case, they assessed the reporting of CONSORT checklist<\/a> items and compliance with practices that support and facilitate open science. The researchers found insufficient reporting of several checklist items, highlighting that 75% of the articles \u201chad selective reporting, lacked primary outcome clarity, or failed to report harms\u201d.<\/p>\n
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75% of the articles [reporting on COVID-19 vaccine trials] \u201chad selective reporting, lacked primary outcome clarity, or failed to report harms\u201d.<\/em><\/p>\n<\/blockquote>\n
Strikingly, while most articles contained data sharing statements, only 25\/36 provided access to individual patient data. Restrictions and limitations relating to data sharing varied markedly and were not always clear. None of the articles provided a direct link to datasets.<\/p>\n
The researchers concluded that reporting and data sharing remain suboptimal and recommend establishing a real-time data sharing system for COVID-19 vaccine trials. The Chinese EQUATOR centre is now developing the VAccine cLinical research reporting gUidEline (VALUE<\/a>) reporting guidelines, which aim to enhance the quality of reporting in vaccine clinical trials. We look forward to seeing the guidelines, which are due to be published later this year.<\/p>\n
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