EMA Advises Using COVID-19 Approaches to Support Ukrainian Clinical Trials
As the Russia-Ukraine war rages, the European Medicines Agency (EMA) has openly addressed the crisis’ disruptions to trials in the Ukraine, calling on sponsors to implement COVID-19 flexibilities and approaches where and when they can.
The agency’s initial advice to sponsors running trials in the war-torn country is to take the lessons learned from the pandemic and apply them to trials that are currently being affected. Specifically, sponsors should refer to the EMA’s guidance on managing trials during the pandemic and guidance on the pandemic’s implications for methodological aspects of trials in progress.
“Certain changes and protocol deviations in the current situation are unavoidable, when for example scheduled study visits cannot take place or arrangements need to be made to transfer trial participants who are fleeing Ukraine to other investigator sites of the same trial in the European Union,” the EMA said. “Adaptations will also be needed to protect the participants’ right and safety, including the continuation of ongoing trial treatment if possible, as well as to preserve the quality of the data generated by the trials.”
The EMA’s recommendations come in response to sponsor inquiries on how trial records, documentation, data collection, protocol deviations and missing data should be handled in light of the war and its disruptions.
A guidance on managing trials during the pandemic includes recommendations for starting new trials; making changes to ongoing trials; maintaining safety reporting; performing risk assessments; communicating with authorities; and other topics.
A guidance on methodological implications advises sponsors not to stop collecting data if at all possible, to perform a risk assessment on potential impact to trial integrity/interpretability and to plan, in advance, how protocol deviations will be captured, among other critical things to consider.
Additional recommendations are being worked on by a group of clinical trial experts, while the EMA is in the process of developing further recommendations on methodological considerations for data coming from Ukrainian trials.
Read the guidance on managing trials during the pandemic here: https://bit.ly/3tWg7UE.
Read the guidance on methodological implications here: https://bit.ly/376dQgk.