The Need for Pediatric Drug Development - 13/12/17
Doi : 10.1016/j.jpeds.2017.08.011
Robert M. Ward, MD, FAAP, FCP 1, * 
, Daniel K. Benjamin, MD, PhD, MPH, FAAP 2, Jonathan M. Davis, MD, FAAP 3, 4, Richard L. Gorman, MD, FAAP, Ralph Kauffman, MD, FAAP, Gregory L. Kearns, PhD, FCP, FAAP 5, Mary Dianne Murphy, MD, FAAP, Catherine M.T. Sherwin, PhD, FCP 1
, Daniel K. Benjamin, MD, PhD, MPH, FAAP 2, Jonathan M. Davis, MD, FAAP 3, 4, Richard L. Gorman, MD, FAAP, Ralph Kauffman, MD, FAAP, Gregory L. Kearns, PhD, FCP, FAAP 5, Mary Dianne Murphy, MD, FAAP, Catherine M.T. Sherwin, PhD, FCP 1 1 Department of Pediatrics, University of Utah, School of Medicine, Salt Lake City, UT
2 Duke Clinical Research Institute, Duke University, Durham, NC
3 Neonatal Advisory Committee in the Office of the FDA Commissioner, Silver Spring, MD
4 Tufts University School of Medicine, Boston, MA
5 Department of Pediatrics, Arkansas Children's Research Institute, University of Arkansas for Medical Sciences, Little Rock, AR
*Reprint requests: Robert M. Ward, MD, FAAP, FCP, Department of Pediatrics-Clinical Pharmacology, University of Utah School of Medicine, 295 Chipeta Way, 1S100, Salt Lake City, UT 84108.Department of Pediatrics-Clinical PharmacologyUniversity of Utah School of Medicine295 Chipeta Way, 1S100Salt Lake CityUT84108
Keywords : pediatric clinical trials, pediatric pharmacology, BPCA, PREA, International Neonatal Consortium, Institute for Advanced Clinical Trials for Children
Abbreviations : AAP, BPCA, CPD, CTSA, CYP, FDA, FDAMA, FDCA, ISPCTN, INC, NICHD, NICU, NIH, PREA, PTC, PTN, T2D, WR
Plan
| R.M.W. is a co-chair of the Clinical Pharmacology Working Group of the International Neonatal Consortium and a member of the Board of Directors of the Institute for Advanced Clinical Trials for Children and receives no funding support. R.M.W. is a consultant for Johnson & Johnson Pharmaceuticals, Shire Genetics, OCON, and Gilead Pharmaceuticals. D.K.B. receives support from the National Institutes of Health (NIH) National Institute of Child Health and Human Development (NICHD), HHSN-275201000003I; National Institute of Allergy and Infectious Diseases (with NICHD), 1T32GM086330; NIH ECHO Program, 1U2COD023375-01; National Center for Advancing Translational Sciences (NCATS), 1U24TR001608-01; CEMPRA Pharmaceuticals and industry for neonatal and pediatric drug development, HHSO100201300009C. J.M.D receives funding from NCATS, UL1 TR001064; National Institute on Drug Abuse, R21 - R21 DA041706; FDA Office of Orphan Products Development, R01 FD003899; and the Charles T. Hood Foundation. G.L.K receives funding from the NICHD Pediatric Trial Network (PTN), HHHSN275010000031; Arkansas Center for Advancing Pediatric Therapeutics NICHD, 1UG1HD090876-01; and the National Center for Complementary and Integrative Health, 1R21AT009101-01. C.M.T.S receives funding from the Primary Children's Hospital Foundation; NIH, 1R01GM121648-01; NCATS, U24TR001597; NICHD PTN, HHSN-2752010000031; FDA/NIH/U.S. Department of Health and Human Services, U01FD005442 and U01FD005191; Pfizer ASPIRE Program; and the E.W. “Al” Thrasher Award. The other authors declare no conflicts of interest. |
© 2017
Elsevier Inc. Tous droits réservés.
Vol 192
P. 13-21 - janvier 2018 Retour au numéro
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