Large scale clinical trials: lessons from the COVID-19 pandemicCitation formats

  • External authors:
  • Nick Schindler
  • Miriam Bennett
  • Rebecca Robey
  • Jane C. Davies
  • Ratko Djukanovic
  • Liam G. Heaney
  • Stefan J. Marciniak
  • Lorcan McGarvey
  • Joanna C Porter
  • Thomas Wilkinson
  • Chris Brightling
  • Ling-Pei Ho

Standard

Large scale clinical trials: lessons from the COVID-19 pandemic. / Horsley, Alexander; Pearmain, Laurence; Knight, Sean; Schindler, Nick; Wang, Ran; Bennett, Miriam; Robey, Rebecca; Davies, Jane C.; Djukanovic, Ratko; Heaney, Liam G.; Hussell, Tracy; Marciniak, Stefan J.; McGarvey, Lorcan; Porter, Joanna C; Wilkinson, Thomas ; Brightling, Chris; Ho, Ling-Pei.

In: BMJ Open Respiratory Research, Vol. 9, No. 1, 06.2022.

Research output: Contribution to journalArticlepeer-review

Harvard

Horsley, A, Pearmain, L, Knight, S, Schindler, N, Wang, R, Bennett, M, Robey, R, Davies, JC, Djukanovic, R, Heaney, LG, Hussell, T, Marciniak, SJ, McGarvey, L, Porter, JC, Wilkinson, T, Brightling, C & Ho, L-P 2022, 'Large scale clinical trials: lessons from the COVID-19 pandemic', BMJ Open Respiratory Research, vol. 9, no. 1. https://doi.org/10.1136/bmjresp-2022-001226

APA

Horsley, A., Pearmain, L., Knight, S., Schindler, N., Wang, R., Bennett, M., Robey, R., Davies, J. C., Djukanovic, R., Heaney, L. G., Hussell, T., Marciniak, S. J., McGarvey, L., Porter, J. C., Wilkinson, T., Brightling, C., & Ho, L-P. (2022). Large scale clinical trials: lessons from the COVID-19 pandemic. BMJ Open Respiratory Research, 9(1). https://doi.org/10.1136/bmjresp-2022-001226

Vancouver

Author

Horsley, Alexander ; Pearmain, Laurence ; Knight, Sean ; Schindler, Nick ; Wang, Ran ; Bennett, Miriam ; Robey, Rebecca ; Davies, Jane C. ; Djukanovic, Ratko ; Heaney, Liam G. ; Hussell, Tracy ; Marciniak, Stefan J. ; McGarvey, Lorcan ; Porter, Joanna C ; Wilkinson, Thomas ; Brightling, Chris ; Ho, Ling-Pei. / Large scale clinical trials: lessons from the COVID-19 pandemic. In: BMJ Open Respiratory Research. 2022 ; Vol. 9, No. 1.

Bibtex

@article{b025a295e5004978a064d933b7ecea34,
title = "Large scale clinical trials: lessons from the COVID-19 pandemic",
abstract = "Background: The 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.Methods: We 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 formal thematic analysis approach to identify common themes and recommendations.Results: 83 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 experience were captured, including early and late phase trials. Responses were coded into over-arching themes. Among common observations, complex protocols without adaptation to a pandemic were noted to have hampered recruitment. There is a 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.Conclusions: Delivery 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. ",
keywords = "COVID-19, respiratory infection, viral infection",
author = "Alexander Horsley and Laurence Pearmain and Sean Knight and Nick Schindler and Ran Wang and Miriam Bennett and Rebecca Robey and Davies, {Jane C.} and Ratko Djukanovic and Heaney, {Liam G.} and Tracy Hussell and Marciniak, {Stefan J.} and Lorcan McGarvey and Porter, {Joanna C} and Thomas Wilkinson and Chris Brightling and Ling-Pei Ho",
year = "2022",
month = jun,
doi = "10.1136/bmjresp-2022-001226",
language = "English",
volume = "9",
journal = "BMJ Open Respiratory Research",
issn = "2052-4439",
publisher = "BMJ ",
number = "1",

}

RIS

TY - JOUR

T1 - Large scale clinical trials: lessons from the COVID-19 pandemic

AU - Horsley, Alexander

AU - Pearmain, Laurence

AU - Knight, Sean

AU - Schindler, Nick

AU - Wang, Ran

AU - Bennett, Miriam

AU - Robey, Rebecca

AU - Davies, Jane C.

AU - Djukanovic, Ratko

AU - Heaney, Liam G.

AU - Hussell, Tracy

AU - Marciniak, Stefan J.

AU - McGarvey, Lorcan

AU - Porter, Joanna C

AU - Wilkinson, Thomas

AU - Brightling, Chris

AU - Ho, Ling-Pei

PY - 2022/6

Y1 - 2022/6

N2 - Background: The 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.Methods: We 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 formal thematic analysis approach to identify common themes and recommendations.Results: 83 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 experience were captured, including early and late phase trials. Responses were coded into over-arching themes. Among common observations, complex protocols without adaptation to a pandemic were noted to have hampered recruitment. There is a 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.Conclusions: Delivery 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.

AB - Background: The 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.Methods: We 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 formal thematic analysis approach to identify common themes and recommendations.Results: 83 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 experience were captured, including early and late phase trials. Responses were coded into over-arching themes. Among common observations, complex protocols without adaptation to a pandemic were noted to have hampered recruitment. There is a 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.Conclusions: Delivery 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.

KW - COVID-19

KW - respiratory infection

KW - viral infection

U2 - 10.1136/bmjresp-2022-001226

DO - 10.1136/bmjresp-2022-001226

M3 - Article

VL - 9

JO - BMJ Open Respiratory Research

JF - BMJ Open Respiratory Research

SN - 2052-4439

IS - 1

ER -