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

Trials invited 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 welcomed the submission of Updates to protocols previously published in Trials that describe changes made because of the COVID-19 pandemic. This collection closed to new submissions on 31st July 2022.

  1. Nen ŨnkUmbi/EdaHiYedo (“We Are Here Now,” or NE) is an intervention to prevent STIs, HIV, HCV, and teen pregnancy among Assiniboine and Sioux youth of the Fort Peck Reservation in the state of Montana in the USA....

    Authors: Michael Anastario, Elizabeth Rink, Paula Firemoon, Nicole Carnegie, Olivia Johnson, Malory Peterson and Ana Maria Rodriguez
    Citation: Trials 2023 24:248
    Content type: Research Published on:

  2. Various psychological issues and serious health concerns during the imposed lockdown by coronavirus disease 2019 (COVID-19) have induced many changes in the treatment of patients. More effective self-managemen...

    Authors: Zohre Khosrokiani, Amir Letafatkar, Malihe Hadadnezhad and Yahya Sokhanguei
    Citation: Trials 2022 23:1031
    Content type: Study protocol Published on:

  3. The aim of this protocol is to describe the study protocol changes made and subsequently implemented to the Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina randomized controlled trial (RCT) for ...

    Authors: Julia Velonjara, Brianna Mills, Silvia Lujan, Gustavo Petroni, Michael J. Bell, Nahuel Guadagnoli, Charles Mock, James P. Hughes, Monica S. Vavilala and Ali Rowhani-Rahbar
    Citation: Trials 2022 23:980
    Content type: Study protocol Published on:

  4. The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and ...

    Authors: Jie Deng, John N. Lukens, Joy C. Cohn, Erin McMenamin, Barbara Murphy, Bryan A. Spinelli, Niya Murphy, Alicia K. Steinmetz, Megan A. Landriau and Alexander Lin
    Citation: Trials 2022 23:927
    Content type: Commentary Published on:

  5. The COVID-19 pandemic forced many research teams to adjust the way they conduct studies, including moving to remote delivery of some or all of their recruitment and data collection processes. The Montreal Cogn...

    Authors: Caroline Brundle, Anne Heaven and Andrew Clegg
    Citation: Trials 2022 23:862
    Content type: Commentary Published on:

  6. The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic...

    Authors: Arnela Suman, Jasmijn van Es, Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan A. Heath, Isla S. Mackenzie, Ghislaine van Thiel and Mira G. P. Zuidgeest
    Citation: Trials 2022 23:856
    Content type: Research Published on:

  7. The COVID-19 pandemic has had a devastating impact on individuals and multiple aspects of our society including healthcare and clinical research. The silver lining is that the pandemic also served as a catalys...

    Authors: Lada Leyens, Tracy Simkins and Nafsika Kronidou Horst
    Citation: Trials 2022 23:833
    Content type: Methodology Published on:

  8. The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Cr...

    Authors: Julie C. Reid, Alex Molloy, Geoff Strong, Laurel Kelly, Heather O’Grady, Deborah Cook, Patrick M. Archambault, Ian Ball, Sue Berney, Karen E. A. Burns, Frederick D’Aragon, Erick Duan, Shane W. English, François Lamontagne, Amy M. Pastva, Bram Rochwerg…
    Citation: Trials 2022 23:735
    Content type: Methodology Published on:

  9. The COVID-19 pandemic impacted nearly all facets of our daily lives, and clinical research was no exception. Here, we discuss the impact of the pandemic on our ongoing, three-arm randomized controlled trial (R...

    Authors: Alaina S. Berruti, Roseann C. Schaaf, Emily A. Jones, Elizabeth Ridgway, Rachel L. Dumont, Benjamin Leiby, Catherine Sancimino, Misung Yi and Sophie Molholm
    Citation: Trials 2022 23:691
    Content type: Commentary Published on:

  10. The torrent of research during the coronavirus (COVID-19) pandemic has exposed the persistent challenges with reporting trials, open science practices, and scholarship in academia. These real-world examples pr...

    Authors: Daeria O. Lawson, Michael K. Wang, Kevin Kim, Rachel Eikelboom, Myanca Rodrigues, Daniela Trapsa, Lehana Thabane and David Moher
    Citation: Trials 2022 23:671
    Content type: Commentary Published on:

  11. Coronavirus disease 2019 (COVID-19) has exposed the disproportionate effects of pandemics on frontline workers and the ethical imperative to provide effective prophylaxis. We present a model for a pragmatic ra...

    Authors: Pepa Bruce, Kate Ainscough, Lee Hatter, Irene Braithwaite, Lindsay R. Berry, Mark Fitzgerald, Thomas Hills, Kathy Brickell, David Cosgrave, Alex Semprini, Susan Morpeth, Scott Berry, Peter Doran, Paul Young, Richard Beasley and Alistair Nichol
    Citation: Trials 2022 23:534
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2022 23:546

  12. Understanding patient and health practitioner perspectives on clinical trials can inform opportunities to enhance trial conduct and design, and therefore patient experience. Patients with haematological cancer...

    Authors: Frances C. Sherratt, Peter Fisher, Amy Mathieson, Mary G. Cherry, Andrew R. Pettitt and Bridget Young
    Citation: Trials 2022 23:509
    Content type: Research Published on:

  13. The COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-...

    Authors: Ricardo Almeida-Magana, Hanna Maroof, Jack Grierson, Rosie Clow, Eoin Dinneen, Tarek Al-Hammouri, Nicola Muirhead, Chris Brew-Graves, John Kelly and Greg Shaw
    Citation: Trials 2022 23:388
    Content type: Methodology Published on:

  14. We conducted in-depth interviews to characterize reasons for COVID-19 vaccine hesitancy in emergency department (ED) patients and developed messaging platforms that may address their concerns. In this trial, w...

    Authors: Robert M. Rodriguez, Kelli O’Laughlin, Stephanie A. Eucker, Anna Marie Chang, Kristin L. Rising, Graham Nichol, Alena Pauley, Hemal Kanzaria, Alexzandra T. Gentsch, Cindy Li, Herbie Duber, Jonathan Butler, Vidya Eswaran and Dave Glidden
    Citation: Trials 2022 23:332
    Content type: Study protocol Published on:

  15. The utilization of mobile health (m-health) has rapidly expanded during the COVID-19 pandemic, and there is still a lack of relevant clinical data pertaining to chronic low-back pain (CLBP) management. This st...

    Authors: Fuming Zheng, Shufeng Liu, Shanshan Zhang, Qiuhua Yu, Wai Leung Ambrose Lo, Tingni Li and Chu Huai Wang
    Citation: Trials 2022 23:190
    Content type: Research Published on:

  16. The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epid...

    Authors: Caroline Cake, Emma Ogburn, Heather Pinches, Garry Coleman, David Seymour, Fran Woodard, Sinduja Manohar, Marjia Monsur, Martin Landray, Gaynor Dalton, Andrew D. Morris, Patrick F. Chinnery, F. D. Richard Hobbs and Christopher Butler
    Citation: Trials 2022 23:62
    Content type: Methodology Published on:

  17. Some pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the ...

    Authors: Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao…
    Citation: Trials 2021 22:857
    Content type: Update Published on:

    The Letter to this article has been published in Trials 2021 22:162

  18. The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites ac...

    Authors: Silke van Koningsbruggen-Rietschel, Fiona Dunlevy, Veerle Bulteel, Kate Hayes, Anne Verbrugge, Hettie M. Janssens, Nadine Dufeu, Nicholas J. Simmonds, Lieven J. Dupont and Damian G. Downey
    Citation: Trials 2021 22:578
    Content type: Commentary Published on:

  19. Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medici...

    Authors: Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayanan, Vivek Gupta, Rashmi Upadhayay, Jitender Kumar, Sathiyarajeswaran Parameswaran, KanakavalliKadarkarai and AarthiVelmurugan
    Citation: Trials 2021 22:570
    Content type: Research Published on:

  21. The COVID-19 pandemic has posed challenges to the conduct of clinical trials. Strategies for overcoming common challenges to non-COVID-19 trial continuation have been reported, but this literature is limited t...

    Authors: Bronwyn Myers, Claire van der Westhuizen, Megan Pool, Nancy Hornsby and Katherine R. Sorsdahl
    Citation: Trials 2021 22:440
    Content type: Commentary Published on:

  22. After the SARS-CoV-2 pandemic took hold in the UK, the ActWELL trial team’s plans to present the trial results to participants and other stakeholders had to change. Instead of face-face events, three online ev...

    Authors: Hanne Bruhn, Annie S. Anderson, Amy Hickman, E. Jane Macaskill and Shaun Treweek
    Citation: Trials 2021 22:381
    Content type: Letter Published on:

    The Research to this article has been published in Trials 2020 21:484

  23. The LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) study has developed an individualised supported self-management approach for physical activity for p...

    Authors: Rachel Lowe, Christy Barlow, Barry Lloyd, Julie Latchem-Hastings, Vincent Poile, Charlotte Scoble, Andrew Dean-Young, Kate Button, Rebecca Playle and Monica Busse
    Citation: Trials 2021 22:286
    Content type: Commentary Published on:

  26. There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the co...

    Authors: Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley and Joseph A. Eustace
    Citation: Trials 2021 22:62
    Content type: Commentary Published on:

  27. The aim of this study is to assess the effectiveness and safety of glucocorticoid infusion pulse therapy to improve the clinical outcomes of patients with COVID-19 pneumonia with elevated inflammatory biomarkers.

    Authors: Iñigo Les Bujanda, Jose Loureiro-Amigo, Ferran Capdevila Bastons, Iñaki Elejalde Guerra, Javier Anniccherico Sánchez, Anna Murgadella-Sancho, Ruth García Rey, Julián Librero López and Julio Sánchez Álvarez
    Citation: Trials 2021 22:43
    Content type: Letter Published on:

  28. As of December, 1st, 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, resulted in more than 1 472 917 deaths worldwide and death toll is still increasing exponentially. Many COVID-19 infected peopl...

    Authors: W. Dioh, M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, G. B. Nair, T. Whitehouse, J. Mariani, M. Latil, S. Camelo, R. Lafont, P. J. Dilda, S. Veillet and S. Agus
    Citation: Trials 2021 22:42
    Content type: Letter Published on:

  29. The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporari...

    Authors: Eleanor J. Mitchell, Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman, Helen Hickey, Garry Meakin, Katy Mironov, Niamh Quann, Natalie Wakefield and Alison McDonald
    Citation: Trials 2020 21:784
    Content type: Commentary Published on:

  30. Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequent...

    Authors: Lynda Constable, Tracey Davidson, Suzanne Breeman, Seonaidh Cotton, Alison McDonald, Samantha Wileman and John Norrie
    Citation: Trials 2020 21:765
    Content type: Commentary Published on: