EMA of­fers method­olog­i­cal con­sid­er­a­tions for tri­als dur­ing Covid-19 pan­dem­ic

The Eu­ro­pean Med­i­cines Agency (EMA) on Wednes­day re­leased for con­sul­ta­tion a new draft guide­line on points that clin­i­cal tri­al spon­sors should con­sid­er on the im­pli­ca­tions of the coro­n­avirus dis­ease (Covid-19) on method­olog­i­cal as­pects of on­go­ing tri­als.

While not­ing that “it is not pos­si­ble to give gen­er­al ap­plic­a­ble ad­vice on how the dif­fer­ent as­pects re­lat­ed to the pan­dem­ic should be han­dled, as im­pli­ca­tions on clin­i­cal tri­als are ex­pect­ed to be man­i­fold,” the EMA’s Bio­sta­tis­tics Work­ing Par­ty calls on spon­sors “to pre-plan how sys­tem­at­ic de­vi­a­tions re­sult­ing from the mea­sures and in­di­vid­ual de­ci­sions re­lat­ed to the Covid-19 pan­dem­ic are cap­tured,” as well as to record such de­vi­a­tions and the re­lat­ed rea­sons for them.

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