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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER