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Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities.
Massaro AN, Boyer B, Gill M, Kim D, Laughon M, Walsh M, Lemmon ME, Pilon B, Baer G; Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants. Massaro AN, et al. Among authors: baer g. J Pediatr. 2024 Jun;269:113972. doi: 10.1016/j.jpeds.2024.113972. Epub 2024 Feb 22. J Pediatr. 2024. PMID: 38401783 No abstract available.
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. 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.
Necrotizing Enterocolitis: Using Regulatory Science and Drug Development to Improve Outcomes.
Caplan MS, Underwood MA, Modi N, Patel R, Gordon PV, Sylvester KG, McElroy S, Manzoni P, Gephart S, Chwals WJ, Turner MA, Davis JM; Necrotizing Enterocolitis Workgroup of the International Neonatal Consortium. Caplan MS, et al. J Pediatr. 2019 Sep;212:208-215.e1. doi: 10.1016/j.jpeds.2019.05.032. Epub 2019 Jun 22. J Pediatr. 2019. PMID: 31235383 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. 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.
325 results