ICH plots ma­jor over­haul of good clin­i­cal prac­tice guide­line

As the vast ma­jor­i­ty of clin­i­cal tri­als con­duct­ed dur­ing the Covid-19 pan­dem­ic were not de­signed to yield ac­tion­able in­for­ma­tion, the in­ter­na­tion­al or­ga­ni­za­tion tasked with align­ing drug reg­u­la­tors on per­ti­nent top­ics is work­ing on ma­jor re­vi­sions to its over-arch­ing guide­line on clin­i­cal tri­als.

In fact, one of the high-lev­el prin­ci­ples of the work-in-progress re­vi­sions that the ICH cir­cu­lat­ed late last month, makes clear: “Clin­i­cal tri­als should gen­er­ate re­li­able re­sults.”

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