Background Traditional end points used in registrational randomized, controlled trials
(RCTs) often do not allow for complete interpretation of the full range of potential clinical …

Abstract Background Current US Food and Drug Administration guidance recommends that
the primary endpoint for complicated urinary tract infection clinical trials be a composite of …

Background Desirability of outcome ranking (DOOR) outcomes, with or without response
adjusted for antibiotic risk (RADAR), are increasingly used in infectious diseases …

Noninferiority trial design and analyses are commonly used to establish the effectiveness of
a new antimicrobial drug for treatment of serious infections such as complicated urinary tract …

Objectives This study considers susceptibility test results obtained over a 6 month period for
Enterobacteriaceae that caused urinary tract infections (UTIs) in the Cork region of Ireland …

Background Desirability of outcome ranking (DOOR) is an innovative approach in clinical
trials to evaluate the global benefits and risks of an intervention. We developed and …

Clinical trials that compare strategies to optimize antibiotic use are of critical importance but
are limited by competing risks that distort outcome interpretation, complexities of …

In this overview, we describe important contributions from the Antibacterial Resistance
Leadership Group (ARLG) to patient care, clinical trials design, and mentorship while …

Objectives The population-level appropriateness of empirical antibiotic therapy can be
conventionally measured by ascertainment of treatment coverage. This method involves a …

We read with interest the recent DOOR/RADAR proposal to transform non-inferiority into
superiority trials1. We agree with the authors that non-inferiority trials are complex to …