Conducting antibacterial trials in pediatric populations has unique challenges, which have contributed to the overall complexity of antibacterial drug development. CTTI’s Pediatric Antibiotic Trials Project aims to identify barriers related to scientific and operational issues in the design and conduct of clinical trials of antibacterial drugs for children, as well as develop recommendations to address these challenges.

After conducting surveys with investigators of pediatric antibiotic clinical trials and community providers, conducting qualitative interviews with parents and industry representatives, and reviewing information in the ClinicalTrials.gov database, we now have a body of evidence to inform this discussion. Findings indicate a multiplicity of real and perceived modifiable barriers to participating in or conducting pediatric antibacterial clinical trials, the need for deeper engagement with parents, and the necessity of effective recommendations to improve the design and conduct of these trials. These findings will be presented at the Pediatric Academic Societies (PAS) 2016 Meeting in Baltimore, MD on April 30 – May 3, 2016.

Poster Topic: Pediatric Trials in Antibacterial Drug Development: Findings from the Clinical Trials Transformation Project
Location: Exhibit Hall F
Date & Time: Saturday, April 30, 2016, from 1:30 – 2:45 PM EST
Speaker: Brian Smith, Duke University School of Medicine