Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study

Area of Science:

• Clinical Trials
• Vaccinology
• Public Health

Background:

• Vaccine trial results and data availability are crucial for healthcare providers, public health policy, and decision-making.
• The extent of reporting and data sharing in COVID-19 vaccine studies remains unclear.
• Inconsistent reporting and data accessibility can impact vaccine adoption and public trust.

Purpose of the Study:

• To assess the reporting and data sharing levels of published COVID-19 vaccine trials.
• To identify common issues in reporting, such as protocol deviations and outcome clarity.
• To provide recommendations for improving future vaccine trial transparency.

Main Methods:

• A cross-sectional study systematically searched 12 databases for COVID-19 vaccine trials up to July 2021.
• Reporting quality was evaluated using the CONSORT checklist.
• Data sharing was assessed through open science practices, analyzing protocol deviations, outcome clarity, and harm reporting.

Main Results:

• Analysis included 36 articles reporting on 40 randomized controlled trials.
• The mean CONSORT checklist score was 29.7, indicating suboptimal reporting.
• While 86.1% had data sharing statements and 69.4% provided source data, 75.0% exhibited issues like protocol deviations or unclear primary outcomes.

Conclusions:

• The reporting and data sharing practices in COVID-19 vaccine trials are not optimal.
• Improvements in reporting and data accessibility are needed for future vaccine research.
• Establishing a comprehensive data sharing system is recommended for enhanced transparency and reliability.