FDA's Anti-Infective Drugs Advisory Committee (AIDAC) is being asked to weigh in on the feasibility of clinical trial designs to streamline the development of antibacterial drugs in the face of "more commonplace bacterial resistance."
In briefing materials released ahead of the Dec. 4 meeting, the agency said it will ask AIDAC to discuss whether smaller than usual clinical studies would be acceptable in a streamlined development program despite increased uncertainty concerning safety and efficacy. The panel also will consider trials at single body sites with larger than usual non-inferiority margins, as well as superiority trials that pool data from multiple infection sites.
AIDAC will discuss whether smaller safety databases of 300-400 patients are acceptable, and trial design options for narrow-spectrum antibacterials where use is limited to one or two microorganisms.