Evidence map›Paper›PMID 36183080›Full record

ArticleTrials2022

What is the purpose of clinical trial monitoring?

Sharon B Love, Victoria Yorke-Edwards, Elizabeth Ward, Rebecca Haydock, Katie Keen, Katie Biggs, Gosala Gopalakrishnan, Lucy Marsh, Lydia O'Sullivan, Lisa Fox and 3 more

Abstract read
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
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  5. Review
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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.

Sharon B LoveMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK. s.love@ucl.ac.uk.ORCID http://orcid.org/0000-0002-6695-5390
Victoria Yorke-EdwardsMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.ORCID https://orcid.org/0000-0002-6465-7330
Elizabeth WardBristol Trials Centre (BTC), BRI Hub (CTEU Bristol), Level 7 Queens Building, Bristol Royal Infirmary, Marlborough Street, Bristol, BS2 8HW, UK.
Rebecca HaydockNottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK.
Katie KeenNHS Blood and Transplant Clinical Trials Unit, Long Road, Cambridge, CB2 0PT, UK.
Katie BiggsClinical Trials Research Unit, ScHARR, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Gosala GopalakrishnanDepartment of Surgery & Cancer, Imperial College London, Hammersmith Campus, 1st Floor, ICTEM Building, Du Cane Road, London, W12 0NN, UK.
Lucy MarshCentre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Lydia O'SullivanHealth Research Board - Trials Methodology Research Network, NUI Galway, University Road, Galway, Ireland.ORCID https://orcid.org/0000-0002-7131-5048
Lisa FoxICR-CTSU, 15 Cotswold Road, Belmont, Sutton, Surrey, SM2 5NG, UK.
Estelle PayerneNorwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
Kerenza HoodCentre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.ORCID https://orcid.org/0000-0002-5268-8631
Garry MeakinNottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK.

Funding

Medical Research Council MC_UU_00004/08Medical Research Council MR/S014357/1
6 · The paper itself

Abstract

backgroundThe sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitoring tools on a strong easily communicated foundation, we identified the need to define monitoring in accessible language.

methodsIn a three-step process, the material from sources that describe clinical trial monitoring were synthesised into principles of monitoring. A poll regarding their applicability was run at a UK national academic clinical trials monitoring meeting.

resultsThe process derived 5 key principles of monitoring: keeping participants safe and respecting their rights, having data we can trust, making sure the trial is being run as it was meant to be, improving the way the trial is run and preventing problems before they happen.

conclusionFrom the many sources mentioning monitoring of clinical trials, the purpose of monitoring can be summarised simply as 5 principles. These principles, given in accessible language, should form a firm basis for discussion of monitoring of clinical trials.

Indexed as

CommunicationTrustClinical Trials as TopicHumansClinical trial monitoringClinical trials methodologyTrial conduct

Identifiers

PMID36183080
PMCPMC9526458

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.