MUCH ADO ABOUT NOTHING: Covid-19 Vaccination for Healthy Children

Oh, what a disaster: all the ACIP members were replaced for no good reason, the best and the brightest.  Now children will die as incompetence rules supreme.  The CDC’s guidance on Covid vaccination of healthy kids is being ignored, being made light of and challenged.  We are looking at governmental Continue reading MUCH ADO ABOUT NOTHING: Covid-19 Vaccination for Healthy Children

CABP TRIAL ENROLLMENT – BUT NOT IN THE USA

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

Microbiological Response as Primary Efficacy Endpoint for Antibacterials

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