Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials - 20/03/20
Doi : 10.1016/j.jpeds.2019.09.060
Jonathan M. Davis, MD 1, ⁎ 
, Gerri R. Baer, MD 2, Susan McCune, MD 2, Agnes Klein, MD 3, Junko Sato, MD 4, Laura Fabbri, PhD 5, Alexandra Mangili, MD 6, Mary A. Short, MS 7, Susan Tansey, MBChB 8, Barry Mangum, PharmD 9, Isamu Hokuto, MD, PhD 10, Hidefumi Nakamura, MD, PhD 11, Thomas Salaets, MD 12, Karel Allegaert, MD, PhD 12, 13, Lynne Yao, MD 14, Michael Blum, MD, MPH 14, Joseph Toerner, MD, MPH 14, Mark Turner, MD 15, Ron Portman, MD 16
for the
, Gerri R. Baer, MD 2, Susan McCune, MD 2, Agnes Klein, MD 3, Junko Sato, MD 4, Laura Fabbri, PhD 5, Alexandra Mangili, MD 6, Mary A. Short, MS 7, Susan Tansey, MBChB 8, Barry Mangum, PharmD 9, Isamu Hokuto, MD, PhD 10, Hidefumi Nakamura, MD, PhD 11, Thomas Salaets, MD 12, Karel Allegaert, MD, PhD 12, 13, Lynne Yao, MD 14, Michael Blum, MD, MPH 14, Joseph Toerner, MD, MPH 14, Mark Turner, MD 15, Ron Portman, MD 16for the
International Neonatal Consortium17
1 The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA
2 US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD
3 Health Canada, Ottawa, Ontario, Canada
4 Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
5 Chiesi Farmaceutici SpA, Parma, Italy
6 Takeda Pharmaceutical Company Limited, Zug, Switzerland
7 Eli Lilly and Co, Indianapolis, IN
8 Independent Consultant Pharmaceutical Physician, Durham, NC
9 Paidion Research Inc, Durham, NC
10 St. Marianna University, Kawasaki, Japan
11 National Center for Child Health and Development, Tokyo, Japan
12 Department of Development and Regeneration, KU Leuven, Leuven, Belgium
13 Department of Pediatrics, Division of Neonatology, Erasmus MC–Sophia Children's Hospital, Rotterdam, the Netherlands
14 US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD
15 Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom
16 Novartis Pharmaceuticals, East Hanover, NJ
17 Critical Path Institute, Tucson, AZ
∗Reprint requests: Jonathan M. Davis, MD, The Floating Hospital for Children at Tufts Medical Center, 800 Washington St, Boston, MA.The Floating Hospital for Children at Tufts Medical Center800 Washington StBostonMA
Abbreviations : AE, CRO, DSMB, EMR, FDA, IRB, MedDRA, SUSAR
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© 2019
Elsevier Inc. Tous droits réservés.
Vol 219
P. 243 - avril 2020 Retour au numéro
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