Spon­sors should flag de­cen­tral­ized as­pects of can­cer tri­als to prep for the post-Covid era, FDA says

As more and more clin­i­cal tri­als dur­ing the pan­dem­ic have har­nessed the pow­er of re­mote as­sess­ments and mod­i­fi­ca­tions, the FDA On­col­o­gy Cen­ter of Ex­cel­lence and the Of­fice of On­co­log­ic Dis­eases are now re­quest­ing that ap­pli­cants vol­un­tar­i­ly add flags to datasets to dis­crim­i­nate be­tween re­mote as­sess­ments and tri­al site as­sess­ments.

The push from the FDA to flag these dif­fer­ences is part of an ef­fort to ame­lio­rate the fact that there is cur­rent­ly no stan­dard way to iden­ti­fy Covid-re­lat­ed mod­i­fi­ca­tions in clin­i­cal tri­al datasets sub­mit­ted to the FDA. And many of these re­mote mod­i­fi­ca­tions were de­ployed in the mid­dle of large on­go­ing can­cer tri­als as a way to min­i­mize Covid risks, the agency said.

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