Data sharing and reporting still suboptimal in vaccine trials
- Researchers from the Chinese and Canadian EQUATOR centres found insufficient reporting and data sharing from COVID-19 vaccine trials.
- The researchers recommended real-time data sharing, and reporting guidelines for vaccine trials are due to be published later this year.
Open 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), the National Institutes of Health (NIH), and Public Library of Science (PLOS) all now require data sharing. The EQUATOR network is also now looking at how to improve both reporting and data sharing for vaccine trials.
In a recent study, researchers from the Chinese and Canadian EQUATOR Centres evaluated 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 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 “had selective reporting, lacked primary outcome clarity, or failed to report harms”.
75% of the articles [reporting on COVID-19 vaccine trials] “had selective reporting, lacked primary outcome clarity, or failed to report harms”.
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.
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) 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.
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