How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of re­al-world ev­i­dence to in­form the FDA’s de­ci­sion-mak­ing con­tin­ues apace, with the agency re­leas­ing new draft guid­ance yes­ter­day on how spon­sors can com­pare out­comes of tri­al par­tic­i­pants re­ceiv­ing a test treat­ment with out­comes in a group of peo­ple ex­ter­nal to the tri­al.

The prac­tice of ex­ter­nal­ly con­trolled tri­als is com­mon, par­tic­u­lar­ly in on­col­o­gy or oth­er dif­fi­cult ar­eas where it’s not eth­i­cal or fea­si­ble to use in­ter­nal con­trols.

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