Indications regarding the management of interventional clinical trials with drugs during the current COVID-19 emergency in Italy

Abstract

The Federation of Italian Cooperative Oncology Groups (FICOG), promoted by the Italian Association of Medical Oncology, brings together the 17 Italian oncological cooperative groups that have developed cancer research in Italy (APRIC, ASTRO, GIM, GIOGer, Foundation GONO, GISCAD Foundation, GOIM, GOIRC, IGG, IMI, ISG, ITMO, MANGO, MEET-URO, Michelangelo Foundation, NIBIT Foundation and MITO). The FICOG, in collaboration with the Italian Data Manager Group, in accordance with the Italian Medicines Agency Communications,1 2 European Medicines Agency Guidance3 4 and the Recommendations of the Italian Ministry of Health5, herein provides some indications on the management of interventional clinical studies with drugs in the course of the current emergency for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic, in order to make the behaviour of the clinical trial centres homogeneous, appropriate and safe. The guarantee of the safety of each patient is the general principle to follow, also prevailing with regard to the benefit expected from the study, and consequently a careful and adequate risk assessment is required before any action foreseen by the protocol for patients enrolled is taken. The justifications for any deviations from the protocol are possible if deemed necessary to ensure the patient's well-being and safety through documentation in the records and timely communication to the sponsor. The pre-eminent role of the investigators in charge of the satellite centres with respect to that of the …