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Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
Davis JM, Baer GR, McCune S, Klein A, Sato J, Fabbri L, Mangili A, Short MA, Tansey S, Mangum B, Hokuto I, Nakamura H, Salaets T, Allegaert K, Yao L, Blum M, Toerner J, Turner M, Portman R; International Neonatal Consortium. Davis JM, et al. Among authors: klein a. J Pediatr. 2020 Apr;219:243-249.e1. doi: 10.1016/j.jpeds.2019.09.060. Epub 2019 Nov 8. J Pediatr. 2020. PMID: 31708158 Free PMC article. No abstract available.
Enrollment of Neonates in More Than One Clinical Trial.
Davis JM, Baer GR, Portman R, Nelson R, Storari L, Aranda JV, Bax R, Zajicek A, Klein A, Turner M, Baygani S, Thomson M, Allegaert K; International Neonatal Consortium. Davis JM, et al. Among authors: klein a. Clin Ther. 2017 Oct;39(10):1959-1969. doi: 10.1016/j.clinthera.2017.09.006. Epub 2017 Oct 4. Clin Ther. 2017. PMID: 28987269 Free article. Review.
Development of a neonatal adverse event severity scale through a Delphi consensus approach.
Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, Klein A, Beauman S, Wade K, Thomson M, Roberts E, Harrison J, Quinn T, Baer G, Davis J, Allegaert K; International Neonatal Consortium. Salaets T, et al. Among authors: klein a. Arch Dis Child. 2019 Dec;104(12):1167-1173. doi: 10.1136/archdischild-2019-317399. Epub 2019 Sep 19. Arch Dis Child. 2019. PMID: 31537552 Free PMC article.
The culture of research communication in neonatal intensive care units: key stakeholder perspectives.
Degl J, Ariagno R, Aschner J, Beauman S, Eklund W, Faro E, Iwami H, Jackson Y, Kenner C, Kim I, Klein A, Short M, Sorrells K, Turner MA, Ward R, Winiecki S, Bucci-Rechtweg C; International Neonatal Consortium. Degl J, et al. Among authors: klein a. J Perinatol. 2021 Dec;41(12):2826-2833. doi: 10.1038/s41372-021-01220-5. Epub 2021 Oct 18. J Perinatol. 2021. PMID: 34663901 Free PMC article.
New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.
Ollivier C, Sun H, Amchin W, Beghetti M, Berger RMF, Breitenstein S, Garnett C, Gullberg N, Hassel P, Ivy D, Kawut SM, Klein A, Lesage C, Migdal M, Nije B, Odermarsky M, Strait J, de Graeff PA, Stockbridge N. Ollivier C, et al. Among authors: klein a. J Am Heart Assoc. 2019 May 21;8(10):e011306. doi: 10.1161/JAHA.118.011306. J Am Heart Assoc. 2019. PMID: 31088189 Free PMC article. No abstract available.
Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 1: efficacy endpoints and disease outcome assessments.
Sun H, Vesely R, Taminiau J, Szitanyi P, Papadopoulos EJ, Isaac M, Klein A, Uzu S, Griebel D, Mulberg AE; International Inflammatory Bowel Disease Working Group. Sun H, et al. Among authors: klein a. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):679-83. doi: 10.1097/MPG.0000000000000306. J Pediatr Gastroenterol Nutr. 2014. PMID: 24866781
Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.
Sun H, Vesely R, Nelson RM, Taminiau J, Szitanyi P, Isaac M, Klein A, Uzu S, Griebel D, Mulberg AE; International Inflammatory Bowel Disease Working Group. Sun H, et al. Among authors: klein a. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):684-8. doi: 10.1097/MPG.0000000000000322. J Pediatr Gastroenterol Nutr. 2014. PMID: 24866782
4,659 results