EMA published a new guidance on Clinical Trial (CT) management during the COVID-19 pandemic and a draft guidance on implications of COVID-19 on methodological aspects of ongoing CTs.
Various challenges exist which result in restrictions of visits to healthcare facilities, increased demands on the health service and changes to trial staff availability. Trial participants may also be required to self-isolate, which can make it difficult for investigators to maintain their medical oversight. These challenges could have an impact on the conduct of trials, such as the completion of trial assessments, completion of trial visits and the provision of Investigational Medicinal Products (IMPs).
The impact of COVID-19 on ongoing trials, on opening new trial sites in an existing trial, on ongoing recruitment and continued involvement of participants in the trial, or on starting of new trials needs to be considered.
