Multiple Trial Designs, Endpoints May Be Best for CF Treatments

No one trial design or endpoint is optimal for inhaled antibiotics for cystic fibrosis (CF) patients infected with a chronic bacterial infection. But any clinical trial of a treatment for CF patients infected with Pseudomonas aeruginosa should show superiority rather than noninferiority, Bruce Montgomery, a senior adviser at Gilead Sciences, said at a recent FDA workshop on developing trial designs for aerosolized antibiotics to treat CF patients.
Clinical Trials Advisor