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Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology

AIM: Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. T...

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Autores principales: Agostinelli, Veronica, Ballatore, Zelmira, Ricci, Giulia, Lucarelli, Alessandra, Burattini, Michela, Mariotti, Lorenzo, Catani, Claudia, Tarantino, Valentina, Berardi, Rossana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Open Exploration Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651351/
https://www.ncbi.nlm.nih.gov/pubmed/38023994
http://dx.doi.org/10.37349/etat.2023.00183
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author Agostinelli, Veronica
Ballatore, Zelmira
Ricci, Giulia
Lucarelli, Alessandra
Burattini, Michela
Mariotti, Lorenzo
Catani, Claudia
Tarantino, Valentina
Berardi, Rossana
author_facet Agostinelli, Veronica
Ballatore, Zelmira
Ricci, Giulia
Lucarelli, Alessandra
Burattini, Michela
Mariotti, Lorenzo
Catani, Claudia
Tarantino, Valentina
Berardi, Rossana
author_sort Agostinelli, Veronica
collection PubMed
description AIM: Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. This review aims to analyze the challenges occurred during a pandemic for the management of enrolled patients (enrollment, use of telemedicine visits, study procedures) and for the clinical trials system (from feasibility to selection visit, site initiation visit, monitorings, use of e-signature, deviations and discontinuations). METHODS: The studies included in the present review were selected from PubMed/Google Scholar/ScienceDirect databases. RESULTS: During the first phase of pandemic many clinical trials were suspended in accrual and, as the pandemic progressed, recommendations were established to guarantee the safety and the continuity of care of enrolled patients. In addition, lot of new strategies was found during the pandemic to reduce the negative consequences on clinical trial performance and to guarantee new opportunities of care in the respect of good clinical practice (GCP) in a bad scenario. CONCLUSIONS: Among all modifiers, investigators would prefer to maintain the positive ones such as pragmatic and simplified trial designs and protocols, reducing in-person visits when not necessary and to minimizing sponsor and contract research organizations (CROs) visits.
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spelling pubmed-106513512023-10-30 Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology Agostinelli, Veronica Ballatore, Zelmira Ricci, Giulia Lucarelli, Alessandra Burattini, Michela Mariotti, Lorenzo Catani, Claudia Tarantino, Valentina Berardi, Rossana Explor Target Antitumor Ther Systematic Review AIM: Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. This review aims to analyze the challenges occurred during a pandemic for the management of enrolled patients (enrollment, use of telemedicine visits, study procedures) and for the clinical trials system (from feasibility to selection visit, site initiation visit, monitorings, use of e-signature, deviations and discontinuations). METHODS: The studies included in the present review were selected from PubMed/Google Scholar/ScienceDirect databases. RESULTS: During the first phase of pandemic many clinical trials were suspended in accrual and, as the pandemic progressed, recommendations were established to guarantee the safety and the continuity of care of enrolled patients. In addition, lot of new strategies was found during the pandemic to reduce the negative consequences on clinical trial performance and to guarantee new opportunities of care in the respect of good clinical practice (GCP) in a bad scenario. CONCLUSIONS: Among all modifiers, investigators would prefer to maintain the positive ones such as pragmatic and simplified trial designs and protocols, reducing in-person visits when not necessary and to minimizing sponsor and contract research organizations (CROs) visits. Open Exploration Publishing 2023 2023-10-30 /pmc/articles/PMC10651351/ /pubmed/38023994 http://dx.doi.org/10.37349/etat.2023.00183 Text en © The Author(s) 2023. https://creativecommons.org/licenses/by/4.0/This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Systematic Review
Agostinelli, Veronica
Ballatore, Zelmira
Ricci, Giulia
Lucarelli, Alessandra
Burattini, Michela
Mariotti, Lorenzo
Catani, Claudia
Tarantino, Valentina
Berardi, Rossana
Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
title Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
title_full Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
title_fullStr Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
title_full_unstemmed Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
title_short Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
title_sort impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651351/
https://www.ncbi.nlm.nih.gov/pubmed/38023994
http://dx.doi.org/10.37349/etat.2023.00183
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