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Jan 21, 2008
 |  BioCentury  |  Regulation

FDA hint on non-inferiority

Two presentations at last week's FDA/Infectious Disease Society of America workshop on community-acquired pneumonia provide potential benchmarks for non-inferiority studies. One estimated antibiotic effect size derived from historical data, and the other baseline response rates extrapolated from treatment failure data and pharmacokinetic/pharmacodynamic data.

The fact that FDA itself did the work for one of the models provides some hope that it is trying to establish workable criteria for CAP studies. Indeed, senior agency officials suggested that sponsors' clinical strategies going forward should be informed by the historical data compiled by the agency.

According to an FDA memo, the goals of the workshop held in Silver Spring, Md., were "to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for CAP, including diagnosis of CAP, effect of antimicrobial treatment for CAP, endpoints for trials of CAP, and statistical issues in analysis of results of trials in CAP."

While the workshop was to discuss both outpatient CAP and CAP requiring hospitalization (hCAP), the bulk of the discussion focused on outpatient CAP.

FDA guidance documents released last fall helped to clarify issues around future development of antibiotic drugs. New drugs to treat self-resolving infections, such as acute bacterial sinusitis (ABS), will now require superiority or placebo-controlled studies to gain approval (see BioCentury, Nov. 5, 2007).

Compounds targeting serious, life-threatening infections such as hCAP still can be tested using a non-inferiority (NI) trial design (see BioCentury, Oct. 29, 2007).

Less clear is how to test compounds for outpatient CAP. At...

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