Cargando…

A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials

BACKGROUND: The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic. This paper presents the results of an exploratory study conducted early in th...

Descripción completa

Detalles Bibliográficos
Autores principales: Suman, Arnela, van Es, Jasmijn, Gardarsdottir, Helga, Grobbee, Diederick E., Hawkins, Kimberly, Heath, Megan A., Mackenzie, Isla S., van Thiel, Ghislaine, Zuidgeest, Mira G. P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535935/
https://www.ncbi.nlm.nih.gov/pubmed/36203202
http://dx.doi.org/10.1186/s13063-022-06706-x
_version_ 1784802883272704000
author Suman, Arnela
van Es, Jasmijn
Gardarsdottir, Helga
Grobbee, Diederick E.
Hawkins, Kimberly
Heath, Megan A.
Mackenzie, Isla S.
van Thiel, Ghislaine
Zuidgeest, Mira G. P.
author_facet Suman, Arnela
van Es, Jasmijn
Gardarsdottir, Helga
Grobbee, Diederick E.
Hawkins, Kimberly
Heath, Megan A.
Mackenzie, Isla S.
van Thiel, Ghislaine
Zuidgeest, Mira G. P.
author_sort Suman, Arnela
collection PubMed
description BACKGROUND: The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic. This paper presents the results of an exploratory study conducted early in the pandemic to gain insight into and describe the experiences of organisations involved in clinical trials, with regard to the impact of COVID-19 on the conduct of trials, and the adoption of decentralised methods prior to, and as mitigation for the impact, of COVID-19. METHODS: A survey with 11 open-ended and four multiple choice questions was conducted in June 2020 among member organisations of the public-private “Trials@Home” consortium. The survey investigated (1) the impact and challenges of COVID-19 on the continuation of ongoing clinical trials, (2) the adoption of decentralised methods in clinical trials prior to and as a mitigation strategy for COVID-19, (3) the challenges of conducting clinical trials during COVID-19, (4) the expected permanency of COVID-19-driven changes to the adoption of decentralised methods in clinical trials, and (5) lessons learned from conducting clinical trials during the COVID-19 pandemic. A thematic, inductive analysis of open survey questions was performed, complemented with descriptive statistics (frequencies and distributions). RESULTS: The survey had a response rate of 81%. All organisations included in the analysis (n = 18) implemented (some) decentralised methods in their clinical trials prior to COVID-19, and 15 (83%) implemented decentralised methods as mitigation for COVID-19. Decentralised methods for IMP supply, patient-health care provider interaction and communication, clinic visits and source document verification were used more often as mitigation strategies than they were used prior to COVID-19. Many respondents expect to maintain those decentralised methods they implemented during COVID-19 in ongoing trials, as well as implement them in future trials. CONCLUSIONS: Decentralised methods are a widely implemented mitigation strategy for trial conduct in the face of the COVID-19 pandemic. The results of this survey show that there is an interest to continue the use of decentralised methods in future trials, but important points of attention have been identified that need solutions to help guide the transition from the traditional trial model to a more decentralised trial model. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06706-x.
format Online
Article
Text
id pubmed-9535935
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-95359352022-10-07 A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials Suman, Arnela van Es, Jasmijn Gardarsdottir, Helga Grobbee, Diederick E. Hawkins, Kimberly Heath, Megan A. Mackenzie, Isla S. van Thiel, Ghislaine Zuidgeest, Mira G. P. Trials Research BACKGROUND: The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic. This paper presents the results of an exploratory study conducted early in the pandemic to gain insight into and describe the experiences of organisations involved in clinical trials, with regard to the impact of COVID-19 on the conduct of trials, and the adoption of decentralised methods prior to, and as mitigation for the impact, of COVID-19. METHODS: A survey with 11 open-ended and four multiple choice questions was conducted in June 2020 among member organisations of the public-private “Trials@Home” consortium. The survey investigated (1) the impact and challenges of COVID-19 on the continuation of ongoing clinical trials, (2) the adoption of decentralised methods in clinical trials prior to and as a mitigation strategy for COVID-19, (3) the challenges of conducting clinical trials during COVID-19, (4) the expected permanency of COVID-19-driven changes to the adoption of decentralised methods in clinical trials, and (5) lessons learned from conducting clinical trials during the COVID-19 pandemic. A thematic, inductive analysis of open survey questions was performed, complemented with descriptive statistics (frequencies and distributions). RESULTS: The survey had a response rate of 81%. All organisations included in the analysis (n = 18) implemented (some) decentralised methods in their clinical trials prior to COVID-19, and 15 (83%) implemented decentralised methods as mitigation for COVID-19. Decentralised methods for IMP supply, patient-health care provider interaction and communication, clinic visits and source document verification were used more often as mitigation strategies than they were used prior to COVID-19. Many respondents expect to maintain those decentralised methods they implemented during COVID-19 in ongoing trials, as well as implement them in future trials. CONCLUSIONS: Decentralised methods are a widely implemented mitigation strategy for trial conduct in the face of the COVID-19 pandemic. The results of this survey show that there is an interest to continue the use of decentralised methods in future trials, but important points of attention have been identified that need solutions to help guide the transition from the traditional trial model to a more decentralised trial model. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06706-x. BioMed Central 2022-10-06 /pmc/articles/PMC9535935/ /pubmed/36203202 http://dx.doi.org/10.1186/s13063-022-06706-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Suman, Arnela
van Es, Jasmijn
Gardarsdottir, Helga
Grobbee, Diederick E.
Hawkins, Kimberly
Heath, Megan A.
Mackenzie, Isla S.
van Thiel, Ghislaine
Zuidgeest, Mira G. P.
A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
title A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
title_full A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
title_fullStr A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
title_full_unstemmed A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
title_short A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
title_sort cross-sectional survey on the early impact of covid-19 on the uptake of decentralised trial methods in the conduct of clinical trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535935/
https://www.ncbi.nlm.nih.gov/pubmed/36203202
http://dx.doi.org/10.1186/s13063-022-06706-x
work_keys_str_mv AT sumanarnela acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT vanesjasmijn acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT gardarsdottirhelga acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT grobbeediedericke acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT hawkinskimberly acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT heathmegana acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT mackenzieislas acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT vanthielghislaine acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT zuidgeestmiragp acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT acrosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT sumanarnela crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT vanesjasmijn crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT gardarsdottirhelga crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT grobbeediedericke crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT hawkinskimberly crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT heathmegana crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT mackenzieislas crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT vanthielghislaine crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT zuidgeestmiragp crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials
AT crosssectionalsurveyontheearlyimpactofcovid19ontheuptakeofdecentralisedtrialmethodsintheconductofclinicaltrials