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COVID-19

Call for papers: Impact of COVID-19 on clinical trials

Trials is inviting submission of manuscripts, long and short, including Letters and Commentaries detailing the enforced changes to trial design; trial management; recruitment; consent process; intervention delivery and follow up as a result of the COVID-19 pandemic. We also welcome submission of Updates to protocols previously published in Trials that describe changes made because of the COVID-19 pandemic.

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Articles

  1. Authors: Carlijn J. M. Wibbelink, Christopher W. Lee, Nathan Bachrach, Sarah K. Dominguez, Thomas Ehring, Saskia M. van Es, Eva Fassbinder, Sandra Köhne, Magda Mascini, Marie-Louise Meewisse, Simone Menninga, Nexhmedin Morina, Sophie A. Rameckers, Kathleen Thomaes, Carla J. Walton, Ingrid G. Wigard…

    Content type: Study protocol

  1. Authors: Lucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Max Cooper, Shani Steer, Justine Boles, Stephen Bremner, Debbie Lambert, David Crook, Gemma Earl, Jean Timeyin and Sumita Verma

    Content type: Study protocol

    The Correction to this article has been published in Trials 2018 19:488

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Big data for randomized trials
Edited by Dr Lars Hemkens

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Sample size calculations and specifying the target difference for randomized trials

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

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Stepped wedge randomized controlled trials
Edited by Prof David Torgerson

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Latest Supplement

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

In Review: an integrated pre-print service for Trials

Trials, in partnership with Research Square, is now offering In Review, a service that allows authors to opt in to upload their manuscript to a free preprint platform when submitting to Springer Nature journals. This service allows authors to:

• Share their work with fellow researchers to read, comment on, and cite even before publication

• Showcase their work to funders and others with a citable DOI while it is still under review

• Track their manuscript - including seeing when reviewers are invited, and when reports are received

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Submissions on complementary and alternative medicine

As a journal dedicated to improve the reporting and publication of clinical trials, we aim to embrace all content that is relevant, including general methodology papers, and research into the trial processes, protocols and statistical analysis plan for randomized controlled trials, as well as traditional research and commentary papers. However, it requires an in-depth subject knowledge to properly evaluate papers on the topic of complementary and alternative medicine to assess the intervention, the design of the trials, as well as the primary and secondary outcomes. Hence we feel it’s better to refer authors of these papers to the journals that are more equipped with the expertise required.

As of 1st September 2021, Trials will no longer be considering papers on the topic of complementary and alternative medicine. We recommend the below journals from the BMC family that can accommodate studies in this area, do please check each journal scope carefully before submitting:

BMC Complementary Medicine and Therapies (accepting study protocols)

Chinese Medicine

Nutrition Journal (accepting study protocols)

Submissions made after 1st September will be referred to Transfer Desk team who will help the authors select a proper destination for their manuscript.

Link your publications with an ORCiD identifier

Trials would like to ask all authors to include their ORCiD identifier when submitting their work to Trials. An ORCiD (Open Researcher and Contributor ID) number uniquely attaches your identity to your research work, such as your articles and datasets. You can get your free personal identifier ​at https://ORCiD.org/register.

Call for papers: Case studies of experience with interim data and IDMCs in RCTs

Edited by: Prof Matthew Sydes (MRC Clinical Trials Unit at UCL)

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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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.

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About the Editors

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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