COVID-19 structured summaries: rapid publication of randomised trial protocols in BMC Trials

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 oftime 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,试验proposed implementing a new, simplified process for handling COVID-19 trial protocols.

An Editorialwritten by the Editors in Chief and Senior Editors of试验was published in April 2020 to describe the project and invite submissions. This process involved thecreation of a simple template for aone-page structured summarybased on the摘要的配偶扩展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 projectand the journal has met our aim to publish summaries within an average of 30 days of submission.

Structured summariespublished作为该项目的一部分,涵盖了诸如病毒测试,COVID-19患者的治疗以及预防和疫苗接种该疾病等主题。该项目的一篇高度访问的文章包括PROFISCOVtrial 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 tMelCOVIDstudy 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,试验will continue to support the transparent reporting of COVID-19-related studies andare alsoinviting submissionsof manuscripts讨论COVID-19大流行的临床试验变化,包括对先前发布的方案的更新。

To find out more about how BMC are celebratingClinical Trials Day 2021, please visit ourdedicated page.

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