Drug­mak­ers seek clar­i­ty on guid­ance on use of place­bo and blind­ing in on­col­o­gy tri­als

A half-dozen bio­phar­ma com­pa­nies are seek­ing fur­ther clar­i­ty from the FDA re­gard­ing draft guid­ance from Au­gust on us­ing a place­bo in cer­tain on­col­o­gy tri­als.

The draft fea­tures the FDA’s thoughts on the eth­i­cal chal­lenges of us­ing a place­bo in ran­dom­ized con­trolled clin­i­cal tri­als for ther­a­pies to treat hema­to­log­ic ma­lig­nan­cy and on­co­log­ic dis­ease. The draft al­so dis­cuss­es blind­ing and un­blind­ing, pa­tient re­port­ed out­comes (PROs) and prac­ti­cal and eth­i­cal con­cerns.

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