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Regulatory News | 16 February 2017 | By Michael Mezher
The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.
According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations.
Furthermore, CTTI says that in many cases, pediatric labeling often comes five or more years after new antibiotics are approved for adult populations.
Specifically, CTTI recommends drugmakers take action to improve pediatric antibiotic use by proactively engaging with regulators and making study design considerations early on in drug development.
First, CTTI says drugmakers should align their studies with international regulators, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in order to support coordinated submissions across different regions.
As early as possible, CTTI says drugmakers should get input from FDA on their initial pediatric investigation plan as early as during adult Phase II trials.
Additionally, CTTI says drugmakers should consider conducting pediatric pharmacokinetic (PK) studies in children "concurrently with adult Phase III trials when appropriate."
Other recommendations include considerations for protocol designs to minimize the burden of the studies for pediatric patients and neonates, broadening eligibility criteria for pediatric studies and providing trial site staff with additional training on informed consent practices for such studies.
Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative