Allphase Pharma Consulting, LLC
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Today’s topic is about the lackluster recruitment of US centers in recent CABP trials. We noticed that Eastern European (EE) centers, specifically from Ukraine, Bulgaria, and Serbia, contribute patients in large numbers, actually making these trials feasible. When sponsors and CROs needed to enroll CABP patients, they could not rely Continue reading CABP TRIAL ENROLLMENT – BUT NOT IN THE USA
We have often mentioned the central importance of microbiological response as an endpoint in trials of antibacterials. This is contrary to other therapeutic areas, in which the etiology is less understood and where surrogate markers are needed. In bacterial infectious diseases we have the luxury of knowing exactly what causes Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials
It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators. There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS – 1