Antibiotic Trials For COPD May Hinge On Patient-Reported Outcomes, FDA Says
Outcomes that are clinically important to patients should be the focus of clinical trials for antibiotics to treat acute bacterial exacerbation of chronic bronchitis in patients with chronic obstructive pulmonary disease, FDA recommends in a 1draft guidance released Aug. 21
You may also be interested in...
Industry efforts to collaborate on drug development issues have moved into the arena of patient-reported outcomes, with a consortium forming to improve ways patients report cancer-related fatigue
Antimicrobial drug sponsors would be willing to conduct placebo-controlled trials in acute exacerbation of chronic bronchitis if FDA required such studies, Bristol-Myers Squibb VP-Infectious Disease & Clinical Development Roger Echols, MD, said
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.