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Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment. This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary endpoint was a non-standard composite efficacy and safety endpoint that Continue reading Gepotidacin ABSSSI – How to Fail Adaptively,
WHO compiles a list of antibacterials in clinical development on a regular basis, the last in mid-2024 [1]. The information is up-to-date and detailed: it provides MoA and antibacterial spectrum, coverage of problem pathogens, the development phase, and whether it can be considered an ‘innovative’ drug (based on a set Continue reading A Critical Review of WHO’s List of Antibacterials in Clinical Development
First and upfront, let’s call this virus WARS*, which stands for Wuhan Associated Respiratory Syndrome. President Xi Jingping called for a war against the new virus, and a war it is. Therefore our acronym makes intuitive sense. The naming of new viruses is getting politized and silly: yes, we need Continue reading Some Thoughts about the New Coronavirus Syndrome and its Transmission