The Safety Critical Medical will vary based on role and occupation

In response to the COVID-19 pandemic, rapid sharing of information about planned clinical trials investigating treatments and vaccines was necessary. In this blog for Clinical Trials Day 2021, we look at the novel reporting of study protocols of COVID-19 randomised trials through the BMC Trials structured summary project over the past year. Due to the urgency of the COVID-19 pandemic, clinical trials were being registered, and participants recruited, at unprecedented speeds which would not allow time for publication of study protocols. We predicted that a lack of time to write a full study protocol article and delays in securing funding could be limiting factors to publication, especially in resource-limited settings and where authors are frontline healthcare workers. Accurately reported protocols are vital for research transparency, reducing the risk of bias in trial results, informing the scientific community about ongoing studies, avoiding duplication, and better coordinating research efforts. Therefore, Trials proposed implementing a new, simplified process for handling COVID-19 trial protocols.

Since I started taking these? I’ve had 2. In 9 months. One time of which I was actually sick with a viral infection. I really don’t think that’s a coincidence. Considering how many you get in a bottle…

An Editorial written by the Editors in Chief and Senior Editors of Trials was published in April 2020 to describe the project and invite submissions. This process involved the creation of a simple template for a one-page structured summary based on the CONSORT extension for abstracts which would be simple for authors to complete and editors to review, whilst still allowing for thorough reporting. This summary would be published alongside the full study protocol document that has not undergone peer-review as an additional file. At the time of writing 158 structured summaries have been published as part of the project and the journal has met our aim to publish summaries within an average of 30 days of submission.

Structured summaries published as part of the project have covered topics such as testing for the virus, treatment of people with COVID-19, and prevention and vaccination against the disease. A highly accessed article from the project includes a summary of the PROFISCOV trial protocol. This trial aims to assess the efficacy and safety of an adsorbed COVID-19 (Inactivated) vaccine candidate manufactured by Sinovac in healthcare professionals, as well as comparing the safety of the vaccine in adult and elderly participants. Another highly accessed publication was the MelCOVID study summary, which describes the protocol of a trial exploring the effect of intravenous melatonin on the mortality of patients with COVID-19 admitted to the intensive care unit.

Moving past the one-year anniversary of this project, Trials will continue to support the transparent reporting of COVID-19-related studies and are also inviting submissions of manuscripts discussing changes to clinical trials as a result of the COVID-19 pandemic, including updates to previously published protocols.

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