It is unprecedented: trial management during the COVID-19 pandemic and beyond
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COMMENTARY
Open Access
It is unprecedented: trial management during the COVID-19 pandemic and beyond Eleanor J. Mitchell1* , Khaled Ahmed2, Suzanne Breeman3, Seonaidh Cotton3, Lynda Constable3, Gillian Ferry3, Kirsteen Goodman4, Helen Hickey5, Garry Meakin1, Katy Mironov6, Niamh Quann7, Natalie Wakefield1 and Alison McDonald3
Abstract 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 temporarily paused (whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial processes, working closely with other members of the research team. This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers’ Network (UKTMN), a national network of trial management professionals managing non-commercial trials. In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collection and management and intervention delivery. In many cases, recruitment has been paused whilst mitigations have been put in place to continue data collection. Innovative solutions have been implemented to ensure we continue, where possible, to deliver high-quality clinical trials. Technology has provided many solutions to these challenges, and trial managers have adapted to new ways of working whilst continuing to deliver their clinical trials. Trial management groups are now faced with new uncertainties around re-starting clinical trials, and it is unclear currently how this will go, though working together with sponsors, funders and site teams is clearly a priority. Clinical trial teams have worked together to ensure their trials have adapted quickly whilst ensuring participant safety is given utmost importance. There are clear examples where the trial community have come together to share experiences and expertise, and this should continue in the future to ensure the innovative practices developed become embedded in the design and conduct of clinical trials in the future. Keywords: COVID-19, Pandemic, Clinical trial, Trial management
* Correspondence: [email protected] 1 Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham NG7 2RD, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as lon
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