EMA Antibacterial Workshop Could Prompt Clinical Trial Changes

Industry concerns discussed during a recent European Medicines Agency (EMA) workshop on antibacterials point to changes that clinical trials sponsors may need to adopt. Academics, regulators and industry representatives came together during the February workshop to discuss ongoing revisions to the agency’s Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections. At the end of April, the agency published a report on the discussions. Industry experts weighed in on issues including how new medicines to treat infections with resistance to many other antibiotics should be evaluated and how studies should be designed.
Clinical Trials Advisor