CTTI Project: ABDD Peds Trials
The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis of public-access data conducted by researchers at Duke University.
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Topics Included: Regulatory Submissions + Approvals
Program: Antibacterial Drug Development
Related Projects: Antibacterial Drug Development HABP/VABP Studies, Antibacterial Drug Development Streamlining HABP/VABP Trials, Antibacterial Drug Development Unmet Need
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Children often respond differently to medications approved for adults, and therefore pediatric trials are required and critically needed for new antibiotics in order to inform dosing, efficacy, and safety.
Use CTTI’s recommendations to design pediatric antibacterial trials that ensure adequate enrollment, decrease the burden on sites and families, understand special considerations for neonates, develop appropriate informed consent procedures, and increase engagement with healthcare providers.
A CTTI paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
These risk factors are important because they could aid in earlier and more accurate diagnosis of HABP/VABP, alleviating roadblocks to enrollment in HABP/VABP clinical trials. Improved enrollment could help speed the development of new antibiotics for HABP/VABP, which can often be deadly for children.
The paper details a study conducted by the Pediatric Trials Network in collaboration CTTI, which used pediatric patients’ electronic health records to identify which patients received qualifying respiratory support or antibiotics for either a lower respiratory infection or undifferentiated sepsis. The study then followed the selected patients until they were either diagnosed with HABP/VABP or discharged from the intensive care unit.
Of 862 newborns, infants, and children younger than 18 who were evaluated, 10 percent of patients receiving respiratory support and 12 percent overall developed HABP/VABP. While risk factors varied by age group, patients showed increased odds of developing HABP/VABP if they:
Increased attention to patients with these high-risk features could lead to improved identification of eligible participants in HABP/VABP antibiotic trials.
Learn more about CTTI’s work to improve the feasibility of HABP/VABP clinical trials.
In an article recently published in Pediatrics, CTTI researchers assess the impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial and antifungal drug trials.
The study, which evaluated pediatric trials conducted between 2007 and 2017, found that nearly two-thirds of pediatric antibacterial and antifungal drug trials were conducted under BPCA or PREA. These trials were more likely to collect pharmacokinetic data and report results than non-BPCA/PREA trials.
However, the overall number of pediatric antibacterial and antifungal drug trials was low, representing less than 1 percent of pediatric trials overall. These trials also rarely enrolled infants up to 30 days old.
The findings show that, while federal legislation is likely having an impact on pediatric antibacterial and antifungal drug trials, more efforts are needed to stimulate these trials and improve the reporting of results.
This study was conducted as part of CTTI’s ABDD Peds Trials Project, which focuses on creating efficient, evidence-based processes to accelerate the development of safe and effective pediatric antibacterial drugs.
Growing rates of antibiotic resistance have made the development of new antibacterial therapies an urgent public health need. This is especially true for the pediatric population, where it may take up to 10 years for clinical trials to determine safety and dosing information.
A CTTI article recently published in Contemporary Clinical Trials Communications shares findings from a survey of 73 investigators to determine facilitators and barriers to the successful conduct of much-needed pediatric antibacterial drug trials. The survey was conducted as part of CTTI’s Peds Trials work.
As outlined in the article, almost all investigators identified two factors as very important facilitators: having strong site staff and adequate funding. Other facilitating factors were related to staff expertise. Investigators rated parent concerns and obtaining consent as the most critical barriers. Other barriers included concerns about the number of blood draws and other invasive procedures, as well as having overly narrow eligibility criteria.
The survey findings suggest three areas in which to focus efforts to help facilitate ongoing pediatric antibacterial drug development:
These results were used to develop CTTI’s actionable recommendations for facilitating and improving antibacterial drug trials in the pediatric population.
In an article recently published in the Journal of the Pediatric Infectious Disease Society (JPIDS), CTTI researchers lay out a roadmap for addressing an urgent public health issue: pediatric antibacterial drug development.
Antibacterial drugs are critically important for treating infectious diseases, but growing rates of antimicrobial resistance have made the development of new antibacterial therapies a priority for researchers and physicians. The problem is especially acute in pediatrics, because even when new drugs are developed for adults, it may be up to 10 years before the pediatric clinical trials needed to provide vital information about safety, effectiveness, and dosing in children are completed. The result of these delays is a chronic shortage of information to guide the use of new therapies in pediatric populations.
The JPIDS article, which was distilled from the results of CTTI research and expert stakeholder meetings, identifies five key areas for action aimed at overcoming barriers to conducting timely and efficient trials of new antibacterial drugs in children, including:
The article reflects recommendations from CTTI’s Pediatric Antibacterial Drug Development Project, which focuses on creating efficient, evidence-based processes for developing, testing, and using antibacterial therapies in children. The “Peds Trials” Project itself is part of the larger CTTI Antibacterial Drug Development Program.
By fostering collaborative approaches that involve all stakeholders, CTTI hopes to accelerate the development of safe and effective pediatric antibacterial drugs—and to equip physicians and other healthcare professionals with the information they need to make the best possible decisions for the health of the children under their care.
