It is unprecedented: trial management during the COVID-19 pandemic and beyond

Eleanor J Mitchell* (Corresponding Author), Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman , Helen Hickey, Garry Meakin, Katy Mironov, Niamh Quann, Natalie Wakefield, Alison McDonald

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

74 Citations (Scopus)
3 Downloads (Pure)


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-1932 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.
Original languageEnglish
Article number784
Pages (from-to)784
Number of pages7
Publication statusPublished - 11 Sept 2020

Bibliographical note

UKTMN is funded by the Nuffield Department of Population Health (NDPH) at the University of Oxford.
We thank Graeme MacLennan, Director of the Centre for Health Care Randomised Trials (CHaRT) for the inspiration for this article and UKTMN members for their input into its content. We also thank the huge clinical trial community, both nationally and internationally, for continuing to run clinical trials in these challenging times, and for regulatory agencies to adapting their processes to enable efficiencies.


  • COVID-19
  • pandemic
  • clinical trial
  • Trial management
  • Clinical trial
  • Pandemic
  • Betacoronavirus/pathogenicity
  • Pandemics
  • Data Accuracy
  • Risk Assessment
  • Humans
  • Risk Factors
  • Workflow
  • Data Collection
  • Coronavirus Infections/diagnosis
  • Host-Pathogen Interactions
  • Clinical Trials Data Monitoring Committees
  • Time Factors
  • Patient Safety
  • Clinical Trials as Topic/methods
  • Research Design
  • Pneumonia, Viral/diagnosis


Dive into the research topics of 'It is unprecedented: trial management during the COVID-19 pandemic and beyond'. Together they form a unique fingerprint.

Cite this