BioCentury
ARTICLE | Regulation

FDA hint on non-inferiority

January 21, 2008 8:00 AM UTC

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...