War in Ukraine may re­quire sig­nif­i­cant tri­al changes, EMA says in new guid­ance

As the war in Ukraine rages on, the Eu­ro­pean Med­i­cines Agency is look­ing to help spon­sors of on­go­ing clin­i­cal tri­als nav­i­gate the dis­rup­tions that are ex­pect­ed to con­tin­ue.

But the EMA isn’t ready to put to­geth­er a one-size-fits-all ap­proach for tri­als im­pact­ed by the on­go­ing con­flict.

“At this point in time, it is not pos­si­ble to pro­vide gen­er­al ad­vice on how dif­fer­ent as­pects re­lat­ed to dis­rup­tions caused by the war in Ukraine should be han­dled, as im­pli­ca­tions on clin­i­cal tri­als are ex­pect­ed to be man­i­fold,” the agency said in new guid­ance pub­lished late last week.

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