Anti-Infective Drugs Advisory Committee
November 7, 2001
Questions for the Advisory Committee (11/2/01)
In your discussion, please comment on the significance of the following and how they contributed to your recommendation: interpretation of the data from clinical-only studies, studies with tympanocentesis at baseline (single-tap), the natural history of the infection, and information from the published literature.
Clinical Trials Issues
3. Current guidance for AOM trial designs suggests one clinical-only study and one single-tap study (which may be non-comparative). Please discuss the following issues
In your discussion, please comment on the merits of studies with clinical information only, studies with tympanocentesis, ideal timing of clinical assessments (end-of-therapy v. later follow-up), and alternative study designs (comparative trials with microbiology, double-tap studies, placebo-controlled studies with early escape).