Trial Designs For Non-Cystic Fibrosis Bronchiectasis May Need Refinement
This article was originally published in The Pink Sheet Daily
FDA public workshop will consider the design of clinical studies testing antibacterial drugs to treat lung damage caused by recurrent infections.
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The agency is holding a public workshop to discuss therapeutic targets and clinical trial design for disease-modifying agents to treat peripheral neuropathy; many products in recent development have faced challenges.
The agency received input on the natural history of the disease and options for measuring exacerbation to assess therapeutic success during a Sept. 7 workshop.
A non-inferiority trial with a pre-specified non-inferiority margin is the most likely design for investigational antibacterial drugs targeted at cUTI, according to FDA draft guidance. Primary efficacy endpoint needs to include resolution of symptoms, on top of microbiological success.