By Ruediger Pankow, Principal Consultant, Clinical Trial Regulatory Services
After only one week since publishing of the first version on 20-Mar-2020, an updated version 2 of “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” has been published on the European Commission’s website EudraLex Volume 10.
In version 2 new sections addressing the safety reporting, the distribution of in vitro diagnostic and medical devices, and to auditing clinical trials have been added, while other sections such as for obtaining the informed consent have been enhanced with further clarification or expanded with additional aspects.
In the newly added section on safety reporting it is re-stated that safety reporting should continue to adhere to EU legal framework and implementing national legislations. However, it is also emphasized that investigators should seek alternatives to collect adverse events from trial subjects in those cases “where per protocol physical visits are reduced or postponed”.
Further details within the EU legislation framework have been added for obtaining the informed consent of trial subjects with COVID-19 infection and resulting physical isolation and where they “lack capacity to consent due to the severity of their medical condition”.
Relevant for new clinical trials is the addition made, that the risk-benefit section in the protocol should address additional risks to the trial subjects along with risk mitigation measures for new clinical trials and reference to further details is then made to the section “risk assessment”.
The guidance remains a set of recommendations to manage clinical trials under the COVID-19 pandemic within the European Union, recognizing that applicable national rules (legislations or guidance) may take precedence. On the other hand, its joint issuing by the European Commission, the European Medicines Agency (EMA), the Clinical Trials Facilitation and Coordination Group (CTFG) of the Heads of Medicines Agencies (HMA), and the Clinical Trials Expert Group (CTEG) of the European Commission, provides relevant stakeholders (sponsors, CROs, investigators) the most harmonized approach for clinical trials within the EU legislation framework.