Evidence map›Paper›PMID 32917258›Full record

ArticleTrials2020

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

Eleanor J Mitchell, Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman, Helen Hickey, Garry Meakin, Katy Mironov and 3 more

Abstract readLetter
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

78 citing papers in PubMed.

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  12. Lessons on Resilient Research: Adapting the Tribal Turning Point Study to COVID-19.American Indian and Alaska native mental health research (Online) · 2022
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18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Eleanor J MitchellNottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK. eleanor.mitchell@nottingham.ac.uk.ORCID http://orcid.org/0000-0002-6998-4533
Khaled AhmedBirmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Suzanne BreemanCentre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Seonaidh CottonCentre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Lynda ConstableCentre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Gillian FerryCentre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Kirsteen GoodmanNMAHP Research Unit, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK.
Helen HickeyLiverpool Clinical Trials Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, L69 3BX, UK.
Garry MeakinNottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK.
Katy MironovOxford Trauma, University of Oxford, NDORMS, Kadoorie Centre, Level 3, John Radcliffe Hospital, Oxford, OX3 9DU, UK.
Niamh QuannLeicester Clinical Trials Unit, College of Life Sciences, University of Leicester, University Road, Leicester, LE1 7RH, UK.
Natalie WakefieldNottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK.
Alison McDonaldCentre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.

Funding

Chief Scientist Office HSRU1
6 · The paper itself

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.

Indexed as

Coronavirus InfectionsPandemicsPneumonia, ViralResearch DesignBetacoronavirusClinical Trials as TopicClinical Trials Data Monitoring CommitteesCOVID-19Data AccuracyData CollectionHost-Pathogen InteractionsHumansPatient SafetyRisk AssessmentRisk FactorsSARS-CoV-2Clinical trialCOVID-19PandemicTrial management

Identifiers

PMID32917258
PMCPMC7484918

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.