FDA fi­nal­izes guid­ance on place­bos and blind­ing for can­cer tri­als

The FDA on Wednes­day fi­nal­ized guid­ance rec­om­mend­ing that drug­mak­ers on­ly use place­bos in can­cer clin­i­cal tri­als in se­lect cir­cum­stances due to eth­i­cal con­cerns that would arise when al­ter­na­tive ther­a­pies are avail­able.

Ac­cord­ing to guid­ance, place­bos should on­ly be con­sid­ered in ran­dom­ized con­trolled tri­als to treat on­co­log­ic dis­ease or hema­to­log­ic ma­lig­nan­cy “when sur­veil­lance is stan­dard of care” or in stud­ies with “cer­tain tri­al de­sign fea­tures (e.g., when the tri­al us­es an add-on de­sign).”

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