In response to the COVID-19 pandemic, a rapid exchange of information was required about planned clinical trials for treatment and vaccines. In this Clinical Trials Day 2021 blog, we take a look at the novel reporting of study protocols from randomized COVID-19 trials as part of the BMC Trials structured summary project last year.

Due to the urgency of the COVID-19 pandemic, clinical trials have been registered and participants recruited at unprecedented rates, leaving no time for study protocols to be published. We predicted a lack of The time to write a full article on the study protocol and delays in securing funding could limit publication, especially in resource constrained environments and when writers are on the front lines in the healthcare sector. Accurately reported protocols are critical to research transparency as they reduce the risk of experimental results being biased, inform the scientific community of ongoing studies, avoid duplication, and better coordinate research efforts. Therefore, tries proposed to implement a new, simplified procedure for handling COVID-19 test protocols.

An editorial written by the editors-in-chief and senior editors of tries was published in April 2020 to describe the project and to submit contributions. This process included the Creation of a simple template for a one-page structured summary based on the CONSORT extension for abstracts, which would be easy for authors to complete and review by editors, while still allowing thorough reporting. This summary will be published with the full study protocol document, which was not peer-reviewed as an additional file. At the time of writing, 158 structured summaries have been published as part of the project and the journal achieved our goal of publishing abstracts within an average of 30 days of submission.

Structured summaries published as part of the project covered topics such as testing for the virus, treating people with COVID-19, and preventing and vaccinating against the disease. A frequently accessed article from the project summarizes the PROFISCOVtProtocol. This study aims to evaluate the efficacy and safety of an adsorbed COVID-19 vaccine candidate (inactivated) manufactured by Sinovac in healthcare professionals and to compare the safety of the vaccine in adult and elderly participants. Another high-access publication was the summary of the MelCOVID study, Describes the protocol of a study examining the effect of intravenous melatonin on mortality in patients with COVID-19 who were admitted to the intensive care unit.

After the one year anniversary of this project tries will continue to support transparent reporting of COVID-19-related studies and are also Inviting manuscripts Discuss changes to clinical trials as a result of the COVID-19 pandemic, including updates to previously published protocols.

T.To find out more about how BMC is celebrating Clinical Trials Day 2021, please visit our dedicated page.

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Medical EvidenceMedicine

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