Antibacterial Trials Can Benefit From Futility Analysis, Genentech Tells FDA

 
• By Cathy Dombrowski

Adaptive designs and studies at multiple infection sites are among industry suggestions to the agency as possible new approaches to developing drugs to fight bacterial infections.

FDA should not only allow, but also encourage adaptive or sequential designs for clinical studies of antibacterial drugs, particularly trials that include futility analyses, Genentech Inc. says in comments on an agency request for input on new approaches to antibacterial development.

With the inclusion of a futility analysis, Genentech points out that if a review of all appropriate endpoints finds “that...

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