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

Research output: Contribution to journalArticlepeer-review

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It is unprecedented : trial management during the COVID-19 pandemic and beyond. / Mitchell, Eleanor J; Ahmed, Khaled; Breeman, Suzanne; Cotton, Seonaidh; Constable, Lynda; Ferry, Gillian; Goodman, Kirsteen; Hickey, Helen; Meakin, Garry; Mironov, Katy; Quann, Niamh; Wakefield, Natalie; McDonald, Alison.

In: Trials, Vol. 21, No. 1, 28.08.2020, p. 784.

Research output: Contribution to journalArticlepeer-review

Harvard

Mitchell, EJ, Ahmed, K, Breeman, S, Cotton, S, Constable, L, Ferry, G, Goodman, K, Hickey, H, Meakin, G, Mironov, K, Quann, N, Wakefield, N & McDonald, A 2020, 'It is unprecedented: trial management during the COVID-19 pandemic and beyond', Trials, vol. 21, no. 1, pp. 784. https://doi.org/10.1186/s13063-020-04711-6

APA

Mitchell, E. J., Ahmed, K., Breeman, S., Cotton, S., Constable, L., Ferry, G., Goodman, K., Hickey, H., Meakin, G., Mironov, K., Quann, N., Wakefield, N., & McDonald, A. (Accepted/In press). It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials, 21(1), 784. https://doi.org/10.1186/s13063-020-04711-6

Vancouver

Author

Mitchell, Eleanor J ; Ahmed, Khaled ; Breeman, Suzanne ; Cotton, Seonaidh ; Constable, Lynda ; Ferry, Gillian ; Goodman, Kirsteen ; Hickey, Helen ; Meakin, Garry ; Mironov, Katy ; Quann, Niamh ; Wakefield, Natalie ; McDonald, Alison. / It is unprecedented : trial management during the COVID-19 pandemic and beyond. In: Trials. 2020 ; Vol. 21, No. 1. pp. 784.

Bibtex

@article{afdbe9dc4fe548a0a72f1c65af21fe4d,
title = "It is unprecedented: trial management during the COVID-19 pandemic and beyond",
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 = "Betacoronavirus/pathogenicity, COVID-19, Clinical Trials Data Monitoring Committees, Clinical Trials as Topic/methods, Coronavirus Infections/diagnosis, Data Accuracy, Data Collection, Host-Pathogen Interactions, Humans, Pandemics, Patient Safety, Pneumonia, Viral/diagnosis, Research Design, Risk Assessment, Risk Factors, SARS-CoV-2, Time Factors, Workflow",
author = "Mitchell, {Eleanor J} and Khaled Ahmed and Suzanne Breeman and Seonaidh Cotton and Lynda Constable and Gillian Ferry and Kirsteen Goodman and Helen Hickey and Garry Meakin and Katy Mironov and Niamh Quann and Natalie Wakefield and Alison McDonald",
year = "2020",
month = aug,
day = "28",
doi = "10.1186/s13063-020-04711-6",
language = "English",
volume = "21",
pages = "784",
journal = "Trials",
issn = "1745-6215",
publisher = "Springer",
number = "1",

}

RIS

TY - JOUR

T1 - It is unprecedented

T2 - trial management during the COVID-19 pandemic and beyond

AU - Mitchell, Eleanor J

AU - Ahmed, Khaled

AU - Breeman, Suzanne

AU - Cotton, Seonaidh

AU - Constable, Lynda

AU - Ferry, Gillian

AU - Goodman, Kirsteen

AU - Hickey, Helen

AU - Meakin, Garry

AU - Mironov, Katy

AU - Quann, Niamh

AU - Wakefield, Natalie

AU - McDonald, Alison

PY - 2020/8/28

Y1 - 2020/8/28

N2 - 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.

AB - 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.

KW - Betacoronavirus/pathogenicity

KW - COVID-19

KW - Clinical Trials Data Monitoring Committees

KW - Clinical Trials as Topic/methods

KW - Coronavirus Infections/diagnosis

KW - Data Accuracy

KW - Data Collection

KW - Host-Pathogen Interactions

KW - Humans

KW - Pandemics

KW - Patient Safety

KW - Pneumonia, Viral/diagnosis

KW - Research Design

KW - Risk Assessment

KW - Risk Factors

KW - SARS-CoV-2

KW - Time Factors

KW - Workflow

U2 - 10.1186/s13063-020-04711-6

DO - 10.1186/s13063-020-04711-6

M3 - Article

C2 - 32917258

VL - 21

SP - 784

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -