A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic
Aim: From the start of the pandemic, several aspects of healthcare policies changed, not least the clinical trials management from recruiting capabilities to the protocol compliance in terms of schedule of procedures, follow-up visits, staff constraints and monitoring. This study aims to assess the...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Open Exploration Publishing Inc.
2023-09-01
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| Series: | Exploration of Targeted Anti-tumor Therapy |
| Subjects: | |
| Online Access: | https://www.explorationpub.com/Journals/etat/Article/1002168 |
| _version_ | 1797690765065846784 |
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| author | Zelmira Ballatore Amalia Goudas Francesco Bozzi Alessandra Lucarelli Michela Burattini Giulia Ricci Francesco Savino Rossana Berardi |
| author_facet | Zelmira Ballatore Amalia Goudas Francesco Bozzi Alessandra Lucarelli Michela Burattini Giulia Ricci Francesco Savino Rossana Berardi |
| author_sort | Zelmira Ballatore |
| collection | DOAJ |
| description | Aim: From the start of the pandemic, several aspects of healthcare policies changed, not least the clinical trials management from recruiting capabilities to the protocol compliance in terms of schedule of procedures, follow-up visits, staff constraints and monitoring. This study aims to assess the impact of the COronaVIrusDisease-2019 (COVID-19) pandemic in the conduction of clinical trials at the site of clinical oncology, Ancona (Italy), to identify the strengths and weaknesses upfront the past emergency, and to select better strategies for future similar situations. Methods: Data from February to July of the years 2019, 2020 and 2021 were collected and three practical parameters of the trial unit were investigated: milestones, performance, and impact. Results: The trials mean numbers were 18, 24, and 23, in 2019, 2020, and 2021 respectively. The pre-Site Initiation Visit (PRE-SIV) rate grew from 66.6% in 2019 to 95.5% in 2021 with a deflection in 2020. Protocol deviations were 40 in the period February-July 2019, in the same period of 2020 the number of deviations increased due to COVID related ones, then there was a significant total decrease in February-July 2021. In 2020 and 2021, all the investigator meetings were online. Conclusions: The growing number of remote Site Initiation Visit (SIV) and meetings over the last 3 years suggests the feasibility of the on-line processes. The significant reduction in protocol deviations during 2021 is probably due to an under check of data during a pandemic. But that is also a possible key indicator of the coping strategy made out by clinical oncology to guarantee the continuity of care in clinical trials and to offer new opportunities of cancer care in a bad scenario such as a pandemic one. |
| first_indexed | 2024-03-12T02:03:52Z |
| format | Article |
| id | doaj.art-0ade5a5b418745ed9971ca20758cd77b |
| institution | Directory Open Access Journal |
| issn | 2692-3114 |
| language | English |
| last_indexed | 2024-03-12T02:03:52Z |
| publishDate | 2023-09-01 |
| publisher | Open Exploration Publishing Inc. |
| record_format | Article |
| series | Exploration of Targeted Anti-tumor Therapy |
| spelling | doaj.art-0ade5a5b418745ed9971ca20758cd77b2023-09-07T06:03:12ZengOpen Exploration Publishing Inc.Exploration of Targeted Anti-tumor Therapy2692-31142023-09-014579380010.37349/etat.2023.00168A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemicZelmira Ballatore0https://orcid.org/0000-0002-5594-4397Amalia Goudas1Francesco Bozzi2Alessandra Lucarelli3 Michela Burattini4Giulia Ricci5Francesco Savino6Rossana Berardi7https://orcid.org/0000-0002-9529-2960Department of Medical Oncology, AOU della Marche, 60126 Ancona, ItalyDepartment of Medical Oncology, AOU della Marche, 60126 Ancona, ItalyMedical Oncology, Università Politecnica delle Marche, 60126 Ancona, ItalyDepartment of Medical Oncology, AOU della Marche, 60126 Ancona, ItalyDepartment of Medical Oncology, AOU della Marche, 60126 Ancona, ItalyDepartment of Medical Oncology, AOU della Marche, 60126 Ancona, ItalyMedical Oncology, Università Politecnica delle Marche, 60126 Ancona, ItalyDepartment of Medical Oncology, AOU della Marche, 60126 Ancona, Italy; Medical Oncology, Università Politecnica delle Marche, 60126 Ancona, ItalyAim: From the start of the pandemic, several aspects of healthcare policies changed, not least the clinical trials management from recruiting capabilities to the protocol compliance in terms of schedule of procedures, follow-up visits, staff constraints and monitoring. This study aims to assess the impact of the COronaVIrusDisease-2019 (COVID-19) pandemic in the conduction of clinical trials at the site of clinical oncology, Ancona (Italy), to identify the strengths and weaknesses upfront the past emergency, and to select better strategies for future similar situations. Methods: Data from February to July of the years 2019, 2020 and 2021 were collected and three practical parameters of the trial unit were investigated: milestones, performance, and impact. Results: The trials mean numbers were 18, 24, and 23, in 2019, 2020, and 2021 respectively. The pre-Site Initiation Visit (PRE-SIV) rate grew from 66.6% in 2019 to 95.5% in 2021 with a deflection in 2020. Protocol deviations were 40 in the period February-July 2019, in the same period of 2020 the number of deviations increased due to COVID related ones, then there was a significant total decrease in February-July 2021. In 2020 and 2021, all the investigator meetings were online. Conclusions: The growing number of remote Site Initiation Visit (SIV) and meetings over the last 3 years suggests the feasibility of the on-line processes. The significant reduction in protocol deviations during 2021 is probably due to an under check of data during a pandemic. But that is also a possible key indicator of the coping strategy made out by clinical oncology to guarantee the continuity of care in clinical trials and to offer new opportunities of cancer care in a bad scenario such as a pandemic one. https://www.explorationpub.com/Journals/etat/Article/1002168coronavirusdisease-2019clinical trialpandemiccancer care |
| spellingShingle | Zelmira Ballatore Amalia Goudas Francesco Bozzi Alessandra Lucarelli Michela Burattini Giulia Ricci Francesco Savino Rossana Berardi A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic Exploration of Targeted Anti-tumor Therapy coronavirusdisease-2019 clinical trial pandemic cancer care |
| title | A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic |
| title_full | A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic |
| title_fullStr | A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic |
| title_full_unstemmed | A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic |
| title_short | A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic |
| title_sort | single experience in the conduction of clinical trial during coronavirusdisease 2019 pandemic |
| topic | coronavirusdisease-2019 clinical trial pandemic cancer care |
| url | https://www.explorationpub.com/Journals/etat/Article/1002168 |
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