Cargando…

Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials

BACKGROUND: During the COVID-19 emergency, IRST IRCCS, an Italian cancer research institute and promoter of no profit clinical studies, adapted its activities and procedures as per European and national guidelines to maintain a high standard of clinical trials, uphold participant safety and guarante...

Descripción completa

Detalles Bibliográficos
Autores principales: Valmorri, Linda, Vertogen, Bernadette, Zingaretti, Chiara, Miserocchi, Anna, Volpi, Roberta, Clemente, Alberto, Bondi, Isabella, Valli, Irene, Rudnas, Britt, Martinelli, Giovanni, Nanni, Oriana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8086972/
https://www.ncbi.nlm.nih.gov/pubmed/33931012
http://dx.doi.org/10.1186/s12874-021-01291-0
_version_ 1783686595263594496
author Valmorri, Linda
Vertogen, Bernadette
Zingaretti, Chiara
Miserocchi, Anna
Volpi, Roberta
Clemente, Alberto
Bondi, Isabella
Valli, Irene
Rudnas, Britt
Martinelli, Giovanni
Nanni, Oriana
author_facet Valmorri, Linda
Vertogen, Bernadette
Zingaretti, Chiara
Miserocchi, Anna
Volpi, Roberta
Clemente, Alberto
Bondi, Isabella
Valli, Irene
Rudnas, Britt
Martinelli, Giovanni
Nanni, Oriana
author_sort Valmorri, Linda
collection PubMed
description BACKGROUND: During the COVID-19 emergency, IRST IRCCS, an Italian cancer research institute and promoter of no profit clinical studies, adapted its activities and procedures as per European and national guidelines to maintain a high standard of clinical trials, uphold participant safety and guarantee the robustness and reliability of the data collected. This study presents the measures adopted by our institute with the aim of providing information that could be useful to other academic centers promoting clinical trials during the pandemic. MAIN TEXT: After an in-depth analysis of European and Italian guidelines and consultation and analysis of publications regarding the actions implemented by international no profit clinical trial promoters during the emergency, we monitored the way in which the institute managed clinical trials, verifying compliance with regulatory guidelines and clinical procedures, and evaluating screening and recruitment trends in studies. During the pandemic, our center activated a new clinical trial for the treatment of patients with COVID-19. A number of procedural changes in clinical trials were also authorized through notified amendments, in accordance with Italian Medicines Agency (AIFA) guidelines. Patient screening and enrolment was not interrupted in any site participating in multicenter interventional clinical trials on drugs. The institute provided clear indications about essential procedures to be followed, identifying those that could be postponed or carried out by telephone/teleconference. All external sites were monitored remotely, avoiding on-site visits. Although home-working was encouraged, the presence of staff in the central office was also guaranteed to ensure the continuity of promoter activities. CONCLUSIONS: Some measures adopted by IRST could also be effective outside of the COVID-19 period, e.g. numerous activities relating to clinical trial management could be performed on a home-working basis, using suitable digital technologies. In the future, electronic medical records and shared guidelines will be essential for the correct identification and management of trial risks, including the protection of the rights and privacy of subjects taking part. Promoter supervision could be increased by implementing centralized monitoring tools to guarantee data quality. Closer collaboration between promoters and local study staff is needed to optimize trial management. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01291-0.
format Online
Article
Text
id pubmed-8086972
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-80869722021-05-03 Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials Valmorri, Linda Vertogen, Bernadette Zingaretti, Chiara Miserocchi, Anna Volpi, Roberta Clemente, Alberto Bondi, Isabella Valli, Irene Rudnas, Britt Martinelli, Giovanni Nanni, Oriana BMC Med Res Methodol Commentary BACKGROUND: During the COVID-19 emergency, IRST IRCCS, an Italian cancer research institute and promoter of no profit clinical studies, adapted its activities and procedures as per European and national guidelines to maintain a high standard of clinical trials, uphold participant safety and guarantee the robustness and reliability of the data collected. This study presents the measures adopted by our institute with the aim of providing information that could be useful to other academic centers promoting clinical trials during the pandemic. MAIN TEXT: After an in-depth analysis of European and Italian guidelines and consultation and analysis of publications regarding the actions implemented by international no profit clinical trial promoters during the emergency, we monitored the way in which the institute managed clinical trials, verifying compliance with regulatory guidelines and clinical procedures, and evaluating screening and recruitment trends in studies. During the pandemic, our center activated a new clinical trial for the treatment of patients with COVID-19. A number of procedural changes in clinical trials were also authorized through notified amendments, in accordance with Italian Medicines Agency (AIFA) guidelines. Patient screening and enrolment was not interrupted in any site participating in multicenter interventional clinical trials on drugs. The institute provided clear indications about essential procedures to be followed, identifying those that could be postponed or carried out by telephone/teleconference. All external sites were monitored remotely, avoiding on-site visits. Although home-working was encouraged, the presence of staff in the central office was also guaranteed to ensure the continuity of promoter activities. CONCLUSIONS: Some measures adopted by IRST could also be effective outside of the COVID-19 period, e.g. numerous activities relating to clinical trial management could be performed on a home-working basis, using suitable digital technologies. In the future, electronic medical records and shared guidelines will be essential for the correct identification and management of trial risks, including the protection of the rights and privacy of subjects taking part. Promoter supervision could be increased by implementing centralized monitoring tools to guarantee data quality. Closer collaboration between promoters and local study staff is needed to optimize trial management. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01291-0. BioMed Central 2021-04-30 /pmc/articles/PMC8086972/ /pubmed/33931012 http://dx.doi.org/10.1186/s12874-021-01291-0 Text en © The Author(s) 2021 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 Commentary
Valmorri, Linda
Vertogen, Bernadette
Zingaretti, Chiara
Miserocchi, Anna
Volpi, Roberta
Clemente, Alberto
Bondi, Isabella
Valli, Irene
Rudnas, Britt
Martinelli, Giovanni
Nanni, Oriana
Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials
title Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials
title_full Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials
title_fullStr Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials
title_full_unstemmed Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials
title_short Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials
title_sort clinical research activities during covid-19: the point of view of a promoter of academic clinical trials
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8086972/
https://www.ncbi.nlm.nih.gov/pubmed/33931012
http://dx.doi.org/10.1186/s12874-021-01291-0
work_keys_str_mv AT valmorrilinda clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT vertogenbernadette clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT zingarettichiara clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT miserocchianna clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT volpiroberta clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT clementealberto clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT bondiisabella clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT valliirene clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT rudnasbritt clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT martinelligiovanni clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials
AT nannioriana clinicalresearchactivitiesduringcovid19thepointofviewofapromoterofacademicclinicaltrials