EU regulators tell sponsors to apply COVID flexibilities to trials impacted by Ukraine war

European regulators on Wednesday advised sponsors to “use the experience gained during the COVID pandemic” in managing clinical trials affected by the war in Ukraine. The advice was requested by study sponsors, who wanted to know how to handle trial records, documentation, data collection, protocol deviations and missing data emanating from trials in this region.

The European Medicines Agency (EMA) released the advice, alongside the European Commission and Heads of Medicines Agencies (HMA).

Regulators acknowledged that “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.”

They said that adaptations will also be necessary to “protect the participants’ rights 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.”

Sponsors were advised to consult two guidances that describe how such flexibilities were applied during the COVID-19 pandemic. They include the Guidance on the management of clinical trials during the COVID-19 pandemic last revised in February 2022, which addresses how to initiate new trials, applying changes to ongoing trials, safety reporting, risk assessment and communicating with health authorities.

The guidance specifies that clinical trials may be changed to allow physical visits to be converted to phone or video visits and allows trials to be halted or paused to slow down the recruitment of participants, or to extend trial duration. It specifies that in “truly exceptional situations” trials can be transferred to investigational sites away from risk zones.

The second document, Points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials was issued in June 2020. (RELATED: EMA revises methodological guidance for trials impacted by COVID-19, Regulatory Focus 29 June 2020)

The guidance said an independent data monitoring committee should be in place for all trials affected by the COVID pandemic to ensure that sponsors can “preserve trial integrity to the greatest extent possible” although it is ultimately up to sponsors to decide whether to modify trials.

Regulators said the Clinical Trials Coordination Group, an HMA group comprised of clinical trial experts, is also developing recommendations to address specific circumstances linked to the war in Ukraine. EMA is also developing additional recommendations on the methodological aspects of data stemming from clinical trials impacted by the war.

Sponsors are also advised to consult guidance at the national level where clinical trials are authorized and supervised.

EMA

EU regulators tell sponsors to apply COVID flexibilities to trials impacted by Ukraine war

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