Pediatric antibacterial and antifungal trials from 2007 to 2017

Joshua T. Thaden, Karen Chiswell, Ian Jaffe, Stephen P. Bergin, William Yang, Andrew Romaine, Jamie Roberts, Sumathi Nambiar, John Farley, Daniel K. Benjamin, P. Brian Smith, Ephraim L. Tsalik

Research output: Contribution to journalReview article

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.

Original languageEnglish (US)
Article numbere20171849
JournalPediatrics
Volume142
Issue number3
DOIs
StatePublished - Sep 1 2018

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ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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Thaden, J. T., Chiswell, K., Jaffe, I., Bergin, S. P., Yang, W., Romaine, A., ... Tsalik, E. L. (2018). Pediatric antibacterial and antifungal trials from 2007 to 2017. Pediatrics, 142(3), [e20171849]. https://doi.org/10.1542/peds.2017-1849

Pediatric antibacterial and antifungal trials from 2007 to 2017. / Thaden, Joshua T.; Chiswell, Karen; Jaffe, Ian; Bergin, Stephen P.; Yang, William; Romaine, Andrew; Roberts, Jamie; Nambiar, Sumathi; Farley, John; Benjamin, Daniel K.; Smith, P. Brian; Tsalik, Ephraim L.

In: Pediatrics, Vol. 142, No. 3, e20171849, 01.09.2018.

Research output: Contribution to journalReview article

Thaden, JT, Chiswell, K, Jaffe, I, Bergin, SP, Yang, W, Romaine, A, Roberts, J, Nambiar, S, Farley, J, Benjamin, DK, Smith, PB & Tsalik, EL 2018, 'Pediatric antibacterial and antifungal trials from 2007 to 2017', Pediatrics, vol. 142, no. 3, e20171849. https://doi.org/10.1542/peds.2017-1849
Thaden JT, Chiswell K, Jaffe I, Bergin SP, Yang W, Romaine A et al. Pediatric antibacterial and antifungal trials from 2007 to 2017. Pediatrics. 2018 Sep 1;142(3). e20171849. https://doi.org/10.1542/peds.2017-1849
Thaden, Joshua T. ; Chiswell, Karen ; Jaffe, Ian ; Bergin, Stephen P. ; Yang, William ; Romaine, Andrew ; Roberts, Jamie ; Nambiar, Sumathi ; Farley, John ; Benjamin, Daniel K. ; Smith, P. Brian ; Tsalik, Ephraim L. / Pediatric antibacterial and antifungal trials from 2007 to 2017. In: Pediatrics. 2018 ; Vol. 142, No. 3.
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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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T1 - Pediatric antibacterial and antifungal trials from 2007 to 2017

AU - Thaden, Joshua T.

AU - Chiswell, Karen

AU - Jaffe, Ian

AU - Bergin, Stephen P.

AU - Yang, William

AU - Romaine, Andrew

AU - Roberts, Jamie

AU - Nambiar, Sumathi

AU - Farley, John

AU - Benjamin, Daniel K.

AU - Smith, P. Brian

AU - Tsalik, Ephraim L.

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N2 - 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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