Pediatric Antibacterial and Antifungal Trials From 2007 to 2017.

Abstract

BACKGROUND AND OBJECTIVES:The impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial or antifungal drug trials is unknown. Our objective was to identify and characterize trials conducted under the BPCA and/or the PREA. METHODS:Pediatric antibacterial and antifungal drug trials with industry or US federal funding registered in clinicaltrials.gov from 2007 to 2017 were identified. Those conducted under BPCA and/or PREA were identified through US Food and Drug Administration and National Institute of Child Health and Human Development databases. RESULTS:Of 17 495 pediatric trials registered on clinicaltrials.gov between October 2007 and September 2017, 122 systemic antibacterial or antifungal drug trials with industry or US federal funding were identified. Of these 122 trials, 98 (80%) involved antibacterials only, 23 (19%) antifungals only, and 1 (1%) both antibacterials and antifungals. These represented <1% (122 of 17 495) of pediatric trials. Neither pediatric antibacterial nor antifungal drug trials commonly enrolled neonates 0 to 30 days old (30% [30 of 99] vs 42% [10 of 24], respectively). Pediatric antibacterial and antifungal trials were commonly industry funded (79% [78 of 99] and 83% [20 of 24], respectively). In total, 65% (79 of 122) of pediatric antibacterial and/or antifungal drug trials were conducted under BPCA and/or PREA. Researchers in trials conducted under BPCA and/or PREA, relative to non-BPCA and/or PREA trials, more often collected pharmacokinetic data (70% [55 of 79] vs 26% [11 of 43]). CONCLUSIONS:Although the majority of pediatric antibacterial and/or antifungal drug trials were conducted under BPCA and/or PREA, the overall number was low. Greater effort is needed to stimulate such trials.

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Citation

Published Version (Please cite this version)

10.1542/peds.2017-1849

Publication Info

Thaden, Joshua T, Karen Chiswell, Ian Jaffe, Stephen P Bergin, William E Yang, Andrew Romaine, Jamie Roberts, Sumathi Nambiar, et al. (2018). Pediatric Antibacterial and Antifungal Trials From 2007 to 2017. Pediatrics, 142(3). pp. e20171849–e20171849. 10.1542/peds.2017-1849 Retrieved from https://hdl.handle.net/10161/21659.

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Scholars@Duke

Thaden

Joshua Thomas Thaden

Assistant Professor of Medicine
Chiswell

Karen Chiswell

Statistical Scientist

Ph.D., North Carolina State University - 2007

I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linked with electronic health record data) and early-phase trials in pediatric populations. My statistical interests include study design, linear and non-linear mixed effects models, survival analysis, biology- and mechanism-based models, and statistical thinking and learning. 

Bergin

Stephen Patrick Bergin

Assistant Professor of Medicine
Benjamin

Daniel Kelly Benjamin

Kiser-Arena Distinguished Professor

Dr. Danny Benjamin is the Principal Investigator and Chair of the National Institute of Child Health and Human Development’s Pediatric Trials Network. The Network is responsible for designing and leading clinical trials of off-patent medicines in children of all ages across all therapeutic areas. The team has established, or is actively studying, the correct dosing and safety of more than 70 of the most commonly used medicines in children. Each of these trials is conducted under an Investigational New Drug (IND) application with guidance from the Food and Drug Administration for labeling.

The Pediatric Trials Network has directly impacted the healthcare of over 90% of American children.

Signature programs of the Network include clinical trials in premature, term infants, breast feeding mothers, and obese children. Over the past 10 years, Danny’s group has enrolled more premature infants, at more sites, in more clinical trials of off-patent anti-infectives under an IND than all other academic medical centers, pharmaceutical companies, and government agencies in the world, combined.

Danny is recognized by the National Institutes of Health as a premiere mentor and educator. His research program serves as a platform to train students and early career investigators. Danny’s group has a clinical research summer program for high school and college students that has a focus on trainees under-represented in medicine, and he is the primary mentor for medical students, residents, subspecialty fellows, and multiple junior faculty. He has been the primary or secondary mentor for 10 faculty who have received career development awards and who have then gone on to secure their own funding.

Danny's service to the community is expressed through his passion for coaching baseball. He has coached over 500 recreation league, travel league, and scholastic baseball games and he is the head coach of Smith Middle School, the 5-year reigning southern conference champions. Danny and his wife own a charitable non-profit that provides athletic and fitness opportunities for disadvantaged school-aged boys and girls.


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