CTTI has released new recommendations to improve the quality and efficiency of research studies used to develop antibacterial drugs for children. In addition, many of the suggested strategies and practices could be applied to streamline clinical trials of other types of drugs and medical devices for children.

“Medically, children are not just little adults, and they need access to treatments that have undergone appropriate evaluation for safety and efficacy in children,” said Daniel Benjamin Jr., MD, PhD, MPH, a pediatric infectious diseases specialist at Duke University. “The CTTI recommendations address many of the common challenges of conducting this research, and if applied widely, can help deliver much-needed information and treatments to benefit our young patients.”

These recommendations resulted from a collaborative effort among research sponsors, parents, investigators, clinicians, and regulators from the US and the EMA (European Medicines Agency), who provided practical suggestions for the timing of pediatric trials, streamlining trial design, facilitating informed consent, and fostering global and community partnerships to conduct trials that can improve children’s health.

The time from approval of a new antibacterial drug for use in adults to pediatric labeling can be 5 years or longer, potentially delaying appropriate use of medicines for this vulnerable group. Antibacterial resistance is on the rise in children, and the very young can be particularly susceptible to severe illness or death from these pathogens. Despite the great need for more treatment options, many trial sponsors have challenges enrolling pediatric patients in antibacterial drug trials.

“These recommendations encourage consultation with the FDA on pediatric study plans early in drug development and emphasize the potential utility of global study networks and streamlining trials,” said Sumathi Nambiar, MD, MPH, Director of the Division of Anti-Infective Products at the U.S. Food & Drug Administration (FDA). “Our mutual goal is to provide data in the drug labeling that will better inform the safe and effective use of antibacterial drugs in children.”

The CTTI recommendations are meant to  help researchers design trials that are less burdensome for families, as well as to support  improved practices for approaching parents for consent during the stressful time of a child’s illness. These recommendations are based on research that showed 80% of clinicians surveyed identified parent concerns about their child participating in research to be a barrier for completing research studies with children. This emphasizes the need for better engagement with parents throughout a clinical trial, including during the initial design stage. “This work matters to the lives of families like mine,” said Breck Gamel, a parent participant in the CTTI effort. CTTI studied other clinician concerns as well, which helped to identify educational gaps in pediatric labeling and the need for better engagement with other healthcare providers.

*These recommendations are the result of CTTI’s ABDD Peds Trials Project.

**To read this press release in full, click here.

Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group.  There are now evidence-based, consensus-driven solutions. Are you ready to do better clinical trials for children?

Join us for a special webinar in which CTTI will unveil new recommendations for improving pediatric antibacterial clinical trials:

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Title: CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trials Project
Date: February 16, 2016 12:00 – 1:00 PM EST (GMT-05:00)
Webinar Link: http://bit.ly/2kYGm7j
Speakers:

• Sumathi Nambiar, U.S. Food and Drug Administration
• John Bradley, University of California, San Diego
• Gary Noel, Johnson and Johnson Pharmaceutical Research and Development

The webinar will include practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials.

Learn these tips and more for making your trials more successful:

• Importance of engaging with regulators early and throughout medical product development
• Methods of streamlining trial design to decrease burden on sites and families
• Special considerations for conducting trials with neonates
• Approaches for improving the informed consent process
• Ways to increase engagement with healthcare providers

Although developed in the context of antibacterial drug development, many of the recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.

This webinar is open to the public. Please feel free to share this invitation with your colleagues.