{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T00:44:01Z","timestamp":1776473041215,"version":"3.51.2"},"reference-count":17,"publisher":"American Academy of Pediatrics (AAP)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,9,1]]},"abstract":"<jats:sec>\n                  <jats:title>BACKGROUND AND OBJECTIVES:<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS:<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS:<\/jats:title>\n                  <jats:p>Of 17\u2009495 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 &amp;lt;1% (122 of 17\u2009495) 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\u2013BPCA and\/or PREA trials, more often collected pharmacokinetic data (70% [55 of 79] vs 26% [11 of 43]).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS:<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.2017-1849","type":"journal-article","created":{"date-parts":[[2018,8,29]],"date-time":"2018-08-29T10:35:18Z","timestamp":1535538918000},"source":"Crossref","is-referenced-by-count":7,"title":["Pediatric Antibacterial and Antifungal Trials From 2007 to 2017"],"prefix":"10.1542","volume":"142","author":[{"given":"Joshua T.","family":"Thaden","sequence":"first","affiliation":[{"name":"Divisions of Infectious Diseases and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Chiswell","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University, Durham, North Carolina;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ian","family":"Jaffe","sequence":"additional","affiliation":[{"name":"Divisions of Infectious Diseases and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen P.","family":"Bergin","sequence":"additional","affiliation":[{"name":"Pulmonary, Allergy, and Critical Care Medicine, and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William E.","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, Maryland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Romaine","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University, Durham, North Carolina;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jamie","family":"Roberts","sequence":"additional","affiliation":[{"name":"Clinical Trials Transformation Initiative, Durham, North Carolina; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumathi","family":"Nambiar","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Farley","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr","given":"Daniel K.","family":"Benjamin","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University, Durham, North Carolina;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P. 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