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COVID-19 randomised trial protocols: rapid publication without barriers

Research into COVID-19 is exploding, as it needs to, and this includes randomised trials. Researchers need to know about these trials, and they need to know quickly. Trials are therefore implementing a new, simplified process for handling COVID-19 trial protocols which is must faster and much simpler for authors. Here, we present a new, simplified process for handling COVID-19 trial protocols.

Articles

  1. Authors: Maxime Billot, Nicolas Naiditch, Claire Brandet, Bertille Lorgeoux, Sandrine Baron, Amine Ounajim, Manuel Roulaud, Aline Roy-Moreau, Géraldine de Montgazon, Elodie Charrier, Lorraine Misbert, Benjamin Maillard, Tanguy Vendeuvre and Philippe Rigoard

    Content type: Study protocol

Article collections

Article collection
Sample size calculations and specifying the target difference for randomized trials

Thematic series
Building capacity for evidence informed trial management
Edited by Dr Roberta Littleford and Prof Shaun Treweek

Thematic series
Stepped wedge randomized controlled trials
Edited by Prof David Torgerson

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Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)

Structured Study Protocols

Trials is experimenting with a new way of structuring study protocols for randomised trials. The simple innovation is to include all 51 SPIRIT headings and item identifiers within the protocol itself. Readers will then benefit from the ability to search by item identifier, which are contained within curly brackets. This is not mandatory and we will continue to consider protocols submitted in other formats.

We have created a template for this new format that contains both SPIRIT and Trials guidance in one place.

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In Review

Trials has launched In Review, a new option that provides authors with on-demand information on the status of their manuscript, enables them to share their work with funders and their research community, and allows their colleagues to comment and collaborate - all whilst their manuscript is under review.

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Aims and scope

Trials encompasses all aspects of the performance and findings of randomized controlled trials in health. We publish articles on general trial methodology and research into trial processes, as well as study protocols and statistical analysis plans for randomized controlled trials, commentaries and traditional results papers - regardless of outcome or significance of findings.

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Peer review mentoring

The Editors endorse peer review mentoring of early career researchers. Find out more here

Thank you to our peer reviewers

The editors and staff of Trials would like to warmly thank our peer reviewers whose comments have helped to shape the journal.

COVID-19 and impact on peer review

As a result of the significant disruption that is being caused by the COVID-19 pandemic we are very aware that many researchers will have difficulty in meeting the timelines associated with our peer review process during normal times.  Please do let us know if you need additional time. Our systems will continue to remind you of the original timelines but we intend to be highly flexible at this time.

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Calls for papers

Call for papers: Big data for randomized trials

We are pleased to announce that Trials is accepting submissions for a new thematic series on using big data for randomized trials. Edited by Dr Lars Hemkens (University Hospital Basel, Switzerland), this series will consider articles that report on what is currently known about using big data or routinely collected data (such as electronic health records, registries or administrative databases) for randomized trials.

Call for papers: The future of pragmatic trials

We are pleased to announce that Trials is accepting submissions for a new thematic series on the future of pragmatic trials. Edited by Professor Marion Campbell (University of Aberdeen, UK) and Professor Sandra Eldridge (Queen Mary University of London, UK), this series will consider articles that report on any topic relevant to the role, definition and use of the pragmatic trial design.

About the Editors

Jeremy Grimshaw, Editor-in-Chief

Jeremy is a Senior Scientist in the Clinical Epidemiology Program at the Ottawa Health Research Institute and Professor of Medicine, University of Ottawa. He holds a Tier 1 Canadian Research Chair in health knowledge transfer and uptake. Professor Grimshaw’s research interests are in implementation and knowledge translation, quality improvement, complex interventions, systematic reviews, cluster randomized trials, quasi-experimental studies and behavioral theories (and their application to professional behavior).

Peter Jüni, Editor-in-Chief

Peter is a clinical epidemiologist and general internist, and the Director of the Applied Health Research Centre (AHRC) at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital. He holds a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases and is a Professor at the Department of Medicine and the Institute of Health Policy, Management and Evaluation at the University of Toronto. Peter is known for his methodological work and for his clinical research on the management of cardiovascular and musculoskeletal disorders. He has had leading roles in major cardiovascular trials, served as a member of several task forces of the European Society of Cardiology, and contributed to the Cochrane Risk of Bias tools for randomized and non-randomized studies.

Tianjing Li, Editor-in-Chief

Tianjing is an Associate Professor in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health (JHBSPH). Dr Li was trained as a physician and subsequently earned her PhD in Epidemiology (Clinical Trials concentration) and MHS in Biostatistics from JHBSPH. The primary goal of Dr Li's research is to develop, evaluate, and disseminate efficient methods for comparing healthcare interventions and to provide trustworthy evidence for decision making. Her core research interests include methodologies for randomized controlled trials, systematic reviews, network meta-analysis, comparative effectiveness research, and patient-centered outcomes research. Dr Li serves as the Associate Director for Cochrane United States and the Director for Research for Cochrane Eyes and Vision US Project.

Shaun Treweek, Editor-in-Chief

Shaun is Professor of Health Services Research in the Health Services Research Unit at the University of Aberdeen, UK.  Prof Treweek’s research interests are mainly in efficient trial design, particularly pragmatic trial design, improved recruitment and retention interventions for trials, the design of studies to generate trial process evidence and the effective presentation of research evidence.  He is leading an initiative called Trial Forge (http://www.trialforge.org) that aims to be more systematic about how we generate and use research evidence in making trial design, conduct, analysis and reporting decisions. 

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