On­col­o­gy re­search mid-pan­dem­ic: Chal­lenges may bring durable in­no­va­tion

Though clin­i­cal re­search, in gen­er­al, has been chal­lenged dur­ing the COVID-19 pan­dem­ic, on­col­o­gy tri­als “have sev­er­al unique con­sid­er­a­tions due to dis­ease sever­i­ty, reg­i­men com­plex­i­ty, and acute care re­quire­ments” that have caused even greater chal­lenges, US FDA of­fi­cials wrote in a new view­point pub­lished in JA­MA On­col­o­gy.

Da­ta in­tegri­ty is­sues and “pan­dem­ic-in­duced pro­to­col de­vi­a­tions” are a con­cern for spon­sors and FDA alike, and the agency has been at­tempt­ing to be as flex­i­ble as is pos­si­ble while safe­guard­ing pa­tient well­be­ing and clin­i­cal tri­al in­tegri­ty, ac­cord­ing to Anand Shah, FDA deputy com­mis­sion­er for med­ical and sci­en­tif­ic af­fairs, Richard Paz­dur, di­rec­tor of the FDA On­col­o­gy Cen­ter of Ex­cel­lence (OCE), and Kushal Kada­ka, health sci­en­tist in the of­fice of the com­mis­sion­er. Tele­health for pa­tient mon­i­tor­ing has bur­geoned dur­ing the pan­dem­ic, for ex­am­ple, an ap­proach that min­i­mizes dis­ease ex­po­sure for vul­ner­a­ble tri­al par­tic­i­pants while al­low­ing da­ta col­lec­tion to con­tin­ue.

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