Antibiotic Stakeholders Discuss Ethics Of Testing Limited Population Drugs In Broader Populations

With an endorsement of non-inferiority trials in its June 2018 draft guidance on the limited population antibacterial drug (LPAD) pathway, the US Food and Drug Administration suggests that clinical trials for such drugs will include a broader patient population than that described by the labeled indication.

But is such an approach ethical? Stakeholders offered competing takes on the question at a 12 July public meeting on the