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

Autor:	Agostinelli V; Department of Medical Oncology, Università Politecnica delle Marche, 60126 Ancona, Italy., Ballatore Z; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Ricci G; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Lucarelli A; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Burattini M; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Mariotti L; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Catani C; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Tarantino V; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy., Berardi R; Department of Medical Oncology, Università Politecnica delle Marche, 60126 Ancona, Italy.; Department of Medical Oncology, Azienda Ospedaliero-Universitaria delle Marche, 60126 Ancona, Italy.
Jazyk:	angličtina
Zdroj:	Exploration of targeted anti-tumor therapy [Explor Target Antitumor Ther] 2023; Vol. 4 (5), pp. 1095-1103. Date of Electronic Publication: 2023 Oct 30.
DOI:	10.37349/etat.2023.00183
Abstrakt:	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. Competing Interests: RB is a consultant/advisory board member for AstraZeneca, Boehringer Ingelheim, Novartis, MSD, Otsuka, Eli-Lilly, Roche, Amgen, GSK, Eisai, Bristol Myers Squibb. ZB is a consultant/advisory board member for Daichii Sanchyo. All other authors declare that they have no conflicts of interest. (© The Author(s) 2023.)
Databáze:	MEDLINE
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