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COVID-19 effect on clinical research: Single-site risk management experience
BACKGROUND: The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Wolters Kluwer - Medknow
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7513789/ https://www.ncbi.nlm.nih.gov/pubmed/33033698 http://dx.doi.org/10.4103/picr.PICR_119_20 |
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author | Ebeid, Fatma Soliman Elsayed |
author_facet | Ebeid, Fatma Soliman Elsayed |
author_sort | Ebeid, Fatma Soliman Elsayed |
collection | PubMed |
description | BACKGROUND: The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come. AIM: The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact. METHODOLOGY: Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center. RESULTS: Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually. CONCLUSION: The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan. |
format | Online Article Text |
id | pubmed-7513789 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer - Medknow |
record_format | MEDLINE/PubMed |
spelling | pubmed-75137892020-10-07 COVID-19 effect on clinical research: Single-site risk management experience Ebeid, Fatma Soliman Elsayed Perspect Clin Res Original Article BACKGROUND: The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come. AIM: The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact. METHODOLOGY: Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center. RESULTS: Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually. CONCLUSION: The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan. Wolters Kluwer - Medknow 2020 2020-07-06 /pmc/articles/PMC7513789/ /pubmed/33033698 http://dx.doi.org/10.4103/picr.PICR_119_20 Text en Copyright: © 2020 Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. |
spellingShingle | Original Article Ebeid, Fatma Soliman Elsayed COVID-19 effect on clinical research: Single-site risk management experience |
title | COVID-19 effect on clinical research: Single-site risk management experience |
title_full | COVID-19 effect on clinical research: Single-site risk management experience |
title_fullStr | COVID-19 effect on clinical research: Single-site risk management experience |
title_full_unstemmed | COVID-19 effect on clinical research: Single-site risk management experience |
title_short | COVID-19 effect on clinical research: Single-site risk management experience |
title_sort | covid-19 effect on clinical research: single-site risk management experience |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7513789/ https://www.ncbi.nlm.nih.gov/pubmed/33033698 http://dx.doi.org/10.4103/picr.PICR_119_20 |
work_keys_str_mv | AT ebeidfatmasolimanelsayed covid19effectonclinicalresearchsinglesiteriskmanagementexperience |