Evidence map›Paper›PMID 35701071›Full record

ArticleBMJ open respiratory research2022

Large scale clinical trials: lessons from the COVID-19 pandemic.

Alex R Horsley, Laurence Pearmain, Sean Knight, Nick Schindler, Ran Wang, Miriam Bennett, Rebecca C Robey, Jane C Davies, Ratko Djukanović, Liam G Heaney and 7 more

Abstract read
In one paragraph

Article in BMJ open respiratory research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Therapeutic potential of microbiome modulation in reproductive cancers.Medical oncology (Northwood, London, England) · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Lessons identified for a future pandemic.The Journal of antimicrobial chemotherapy · 2023
    Article
  13. Article
  14. Article
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

17 authors.

Alex R HorsleyDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Medical and Human Sciences, Manchester, UK alexander.horsley@manchester.ac.uk.ORCID 0000-0003-1828-0058
Laurence PearmainDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Medical and Human Sciences, Manchester, UK.
Sean KnightDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Medical and Human Sciences, Manchester, UK.
Nick SchindlerInstitute of Continuing Education, University of Cambridge, Cambridge, UK.
Ran WangDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Medical and Human Sciences, Manchester, UK.
Miriam BennettDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Medical and Human Sciences, Manchester, UK.
Rebecca C RobeyDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Medical and Human Sciences, Manchester, UK.
Jane C DaviesNational Heart & Lung Institute, Imperial College London, London, UK.
Ratko DjukanovićSchool of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton School of Medicine, Southampton, UK.
Liam G HeaneyCentre of Infection and Immunity, Queen's University Belfast, Belfast, UK.
Tracy HussellManchester Centre for Infection and Inflammation Research, The University of Manchester Faculty of Biology Medicine and Health, Manchester, UK.
Stefan J MarciniakCambridge Institute for Medical Research, University of Cambridge, Cambridge, UK.ORCID 0000-0001-8472-7183
Lorcan P McGarveyWellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Joanna PorterCentre for Inflammation & Tissue Repair, University College London Division of Medicine, London, UK.
Tom WilkinsonClinical and Experimental Medicine, University of Southampton School of Medicine, Southampton, UK.
Chris BrightlingInstitute of Lung Health, University of Leicester, Leicester, UK.ORCID 0000-0002-5803-5121
Ling-Pei HoMRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, Oxford, UK.

Funding

Department of Health
6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic has presented substantial new challenges to clinical and research teams. Our objective was to analyse the experience of investigators and research delivery staff regarding the research response to COVID-19 in order to identify these challenges as well as solutions for future pandemic planning.

methodsWe conducted a survey of diverse research staff involved in delivery of COVID-19 clinical trials across the UK. This was delivered online across centres linked to the NIHR Respiratory Translational Research Collaboration. Responses were analysed using a formal thematic analysis approach to identify common themes and recommendations.

results83 survey participants from ten teaching hospitals provided 922 individual question responses. Respondents were involved in a range of research delivery roles but the largest cohort (60%) was study investigators. A wide range of research experiences were captured, including early and late phase trials. Responses were coded into overarching themes. Among common observations, complex protocols without adaptation to a pandemic were noted to have hampered recruitment. Recommendations included the need to develop and test pandemic-specific protocols, and make use of innovations in information technology. Research competition needs to be avoided and drug selection processes should be explicitly transparent.

conclusionsDelivery of clinical trials, particularly earlier phase trials, in a pandemic clinical environment is highly challenging, and was reactive rather than anticipatory. Future pandemic studies should be designed and tested in advance, making use of pragmatic study designs as far as possible and planning for integration between early and later phase trials and regulatory frameworks.

Indexed as

COVID-19Data CollectionHumansPandemicsResearch DesignCOVID-19respiratory infectionviral infection

Identifiers

PMID35701071
PMCPMC9198385

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.