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.
Type
Journal articleSubject
HumansCommunicable Diseases
Anti-Bacterial Agents
Antifungal Agents
Drug Industry
Child
United States
Clinical Trials as Topic
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https://hdl.handle.net/10161/21659Published Version (Please cite this version)
10.1542/peds.2017-1849Publication Info
Thaden, Joshua T; Chiswell, Karen; Jaffe, Ian; Bergin, Stephen P; Yang, William E;
Romaine, Andrew; ... Tsalik, Ephraim L (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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Daniel Kelly Benjamin Jr.
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. E
Stephen Patrick Bergin
Assistant Professor of Medicine
Karen Chiswell
Statistical Scientist
Ph.D., North Carolina State University - 2007I 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 linke
Phillip Brian Smith
Samuel L. Katz Distinguished Professor of Pediatrics
Dr. Smith completed his residency in pediatrics and a fellowship in neonatal medicine
at Duke University Medical Center in 2004 and 2007, respectively. He completed an
MHS in clinical research from Duke University in 2006 and an MPH in biostatistics
from the University of North Carolina at Chapel Hill in 2009. His research is focused
on pediatric drug safety, neonatal pharmacology, and the epidemiology of neonatal
infections. Dr. Smith is or has been the protocol chair for more than 14 studie
Joshua Thomas Thaden
Assistant Professor of Medicine
Ephraim Tsalik
Adjunct Associate Professor in the Department of Medicine
My research at Duke has focused on understanding the dynamic between host and pathogen
so as to discover and develop host-response markers that can diagnose and predict
health and disease. This new and evolving approach to diagnosing illness has the
potential to significantly impact individual as well as public health considering
the rise of antibiotic resistance.
With any potential infectious disease diagnosis, it is difficult, if not impossible,
to determine at the time of pre
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