Program: Antibacterial Drug Development (ABDD)

Program:

Antibacterial Drug Development (ABDD)

Addressing challenges in pediatric clinical trials for antibacterial drugs

Pediatric trials are urgently needed for the development of new antibacterial drugs, but these trials can be especially difficult to design, enroll, and complete. In fact, a CTTI review of ClinicalTrials.gov revealed that antibacterial drug trials represented less than 1% of all registered pediatric studies between 2007 and 2010.

To identify the challenges involved in pediatric antibacterial drug trials, CTTI conducted in-depth interviews with parents and industry representatives, as well as surveys of investigators and pediatric providers. It also convened an expert meeting to solicit feedback and develop consensus on workable mechanisms for improving the conduct and execution of antibacterial drug trials in the pediatric population.

With the input of these diverse stakeholders, CTTI has developed actionable, evidence-based recommendations that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials. These include tips on determining the timing of pediatric trials, methods for streamlining trial design to decrease burden on sites and families, and ways to increase engagement with healthcare providers. Many of these recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.