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Items: 1 to 20 of 27

1.

Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

Desselas E, Pansieri C, Leroux S, Bonati M, Jacqz-Aigrain E.

PLoS One. 2017 Feb 13;12(2):e0171760. doi: 10.1371/journal.pone.0171760. eCollection 2017.

2.

Academic pediatric clinical research: factors associated with study implementation duration.

Meier-Girard D, Tibi A, Abdoul H, Prot-Labarthe S, Brion F, Bourdon O, Alberti C.

BMC Med Res Methodol. 2016 Mar 29;16:36. doi: 10.1186/s12874-016-0138-y.

3.

Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension.

Dodgen AL, Hill KD.

Drug Healthc Patient Saf. 2015 Dec 15;7:175-83. doi: 10.2147/DHPS.S65571. eCollection 2015. Review.

5.

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

Hill KD, Henderson HT, Hornik CP, Li JS.

Cardiol Young. 2015 Aug;25 Suppl 2:172-80. doi: 10.1017/S1047951115000980. Review.

6.

New mechanistic and therapeutic targets for pediatric heart failure: report from a National Heart, Lung, and Blood Institute working group.

Burns KM, Byrne BJ, Gelb BD, Kühn B, Leinwand LA, Mital S, Pearson GD, Rodefeld M, Rossano JW, Stauffer BL, Taylor MD, Towbin JA, Redington AN.

Circulation. 2014 Jul 1;130(1):79-86. doi: 10.1161/CIRCULATIONAHA.113.007980. No abstract available.

7.

Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.

Hill KD, Chiswell K, Califf RM, Pearson G, Li JS.

Am Heart J. 2014 Jun;167(6):921-9.e2. doi: 10.1016/j.ahj.2014.02.002. Epub 2014 Feb 17.

8.

Postmarketing trials and pediatric device approvals.

Hwang TJ, Kesselheim AS, Bourgeois FT.

Pediatrics. 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348. Epub 2014 Apr 14.

9.

Clinical trials in children.

Joseph PD, Craig JC, Caldwell PH.

Br J Clin Pharmacol. 2015 Mar;79(3):357-69. doi: 10.1111/bcp.12305. Review.

10.

How to improve the implementation of academic clinical pediatric trials involving drug therapy? A qualitative study of multiple stakeholders.

Girard D, Bourdon O, Abdoul H, Prot-Labarthe S, Brion F, Tibi A, Alberti C.

PLoS One. 2013 May 28;8(5):e64516. doi: 10.1371/journal.pone.0064516. Print 2013.

11.

Therapeutic hypothermia after pediatric cardiac arrest trials: the vanguard phase experience and implications for other trials.

Pemberton VL, Browning B, Webster A, Dean JM, Moler FW.

Pediatr Crit Care Med. 2013 Jan;14(1):19-26. doi: 10.1097/PCC.0b013e31825b860b.

12.

Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry.

Pasquali SK, Lam WK, Chiswell K, Kemper AR, Li JS.

Pediatrics. 2012 Nov;130(5):e1269-77. doi: 10.1542/peds.2011-3565. Epub 2012 Oct 1.

13.

An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.

Kesselheim AS.

Milbank Q. 2011 Sep;89(3):450-502. doi: 10.1111/j.1468-0009.2011.00636.x. Review.

14.

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

Walden A, Nahm M, Barnett ME, Conde JG, Dent A, Fadiel A, Perry T, Tolk C, Tcheng JE, Eisenstein EL.

Stud Health Technol Inform. 2011;164:82-8.

15.

Clinical research careers: reports from a NHLBI pediatric heart network clinical research skills development conference.

Lai WW, Vetter VL, Richmond M, Li JS, Saul JP, Mital S, Colan SD, Newburger JW, Sleeper LA, McCrindle BW, Minich LL, Goldmuntz E, Marino BS, Williams IA, Pearson GD, Evans F, Scott JD, Cohen MS.

Am Heart J. 2011 Jan;161(1):13-67. doi: 10.1016/j.ahj.2010.08.032. Review.

16.

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

Thomson D, Hartling L, Cohen E, Vandermeer B, Tjosvold L, Klassen TP.

PLoS One. 2010 Sep 30;5(9). pii: e13106. doi: 10.1371/journal.pone.0013106.

17.

Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity.

Pasquali SK, Burstein DS, Benjamin DK Jr, Smith PB, Li JS.

Pediatrics. 2010 Sep;126(3):e687-92. doi: 10.1542/peds.2010-0098. Epub 2010 Aug 23.

18.
19.

Safety and transparency of pediatric drug trials.

Benjamin DK Jr, Smith PB, Sun MJ, Murphy MD, Avant D, Mathis L, Rodriguez W, Califf RM, Li JS.

Arch Pediatr Adolesc Med. 2009 Dec;163(12):1080-6. doi: 10.1001/archpediatrics.2009.229.

20.

Access to prescribing information for paediatric medicines in the USA: post-modernization.

Young L, Lawes F, Tordoff J, Norris P, Reith D.

Br J Clin Pharmacol. 2009 Mar;67(3):341-6. doi: 10.1111/j.1365-2125.2008.03356.x. Epub 2008 Dec 10.

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